Clinical Quality Assurance Specialist - Pediatrics UNC HealthClinical Quality Assurance Specialist - PediatricsMorrisville, NC$35.87–$51.57 / hourPromotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives. In this role, the objectives would include improving clinical care as well as clinical documentation and reporting for treatment, prevention, and drug administration regimens, record keeping practices, workflow procedures, medical decision-making practices, and pay-for-performance programs.
Clinical Quality Assurance Specialist - Trauma Program UNC HealthClinical Quality Assurance Specialist - Trauma ProgramChapel Hill, NC$35.87–$51.57 / hourp>About the Role: Lead trauma process improvement and patient safety initiatives for a Level I Adult & Pediatric Trauma Center, utilizing data-driven quality improvement strategies to enhance patient outcomes and reduce preventable trauma-related morbidity and mortality. Promotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives.
Clinical Quality Assurance Specialist - UNC OB-GYN at Panther Creek UNC HealthClinical Quality Assurance Specialist - UNC OB-GYN at Panther CreekCary, NC$35.87–$51.57 / hourli>Promotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives. Assists OBGYN dept with meeting our Women's Health Improvement Collaborative goals for screening/treatment of depression, Social Drivers of Health, 5Ps, cervical cancer & breast cancer screenings.
NewQA Specialist (Hybrid) EisaiQA Specialist (Hybrid)Raleigh, NC$66,200–$86,800 / yearli>Technical: Experience or familiarity with Quality Management Systems (e.g., Veeva, TrackWise) Demonstrated experience across key quality assurance functions in a GMP setting (e.g., batch record review, batch release functions, GxP document archival, as applicable). The QA Specialist, EMQO supports Quality Assurance activities at the Eisai Raleigh facility by assisting with routine operational quality tasks under direction and supervision.
QA Analyst Computer Task Group, IncQA AnalystRaleigh, NCQualifications & Education: Bachelor's Degree in Computer Science or Information Technology or equivalent professional experience • 5+ years of relevant technical QA experience or similar role • Retail, Fuel Pharmacy, Restaurant, or POS experience is a big plus Technical Skills: • Office Skills (Word, Excel, PPT) o Basic SQL / Databases o Basic Linux o XML o Ability to work with various QA/Testing tools and technologies (i.e. Jira, Testlink, SOAP UI, Postman) o Scripting (Python) experience is advantage • Problem analysis • Retail Process Knowledge (Retail Experience) a big plus o POS / Backoffice o Store processes o ERP Competencies: Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; designs work flows and procedures. Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
NewQA Specialist (Hybrid) Eisai IncQA Specialist (Hybrid)Raleigh, NC$66,200–$86,800 / yearFor additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.
Senior QA Specialist, External Manufacturing, US Bavarian Nordic ASSenior QA Specialist, External Manufacturing, USDurham, NCRemote$120,000–$155,000 / yearAs a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing quality oversight of external manufacturing partners.
KBI: US - Principal QA Specialist KBI Biopharma IncKBI: US - Principal QA SpecialistDurham, NC$113,000–$156,000 / yearProvides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients.
Quality Assurance Specialist II TalentBurst, Inc.Quality Assurance Specialist II20 TW Alexander Dr, Research Triangle Park,, NC$30–$32 / hourExamples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. Education/ Qualifications:Quality Assurance Specialist - Bachelor's degree, in a health care or relevant scientific field and 3+ years of relevant industry experience.
KBI: US - Principal QA Specialist KBI BiopharmaKBI: US - Principal QA SpecialistDurham, North CarolinaProvides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients.
NewManufacturing QA Specialist Guerbet SAManufacturing QA SpecialistRaleigh, NCWhen you join Guerbet, you : Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
NewQA Specialist (GMP) – 3rd Shift | $27.50/hr | 3 Month Contract | Onsite Manpower EngineeringQA Specialist (GMP) – 3rd Shift | $27.50/hr | 3 Month Contract | OnsiteMebane, NC$27.10–$27.50 / hourTemporaryp>ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
NewQA Specialist – Medical Device Manufacturing | 2nd Shift | $27+/hr | Manpower EngineeringQA Specialist – Medical Device Manufacturing | 2nd Shift | $27+/hr |Mebane, NC$27.10–$27.50 / hourTemporaryp>ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
Quality Assurance Specialist - Lab IntelliPro GroupQuality Assurance Specialist - LabResearch Triangle Park, North CarolinaExamples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team.
Quality Assurance Specialist II Leadstack IncQuality Assurance Specialist IIResearch Triangle Park, NC$33–$33 / hourExamples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. Akarsh YathirajSenior Recruiter C.(415) 322-5419D.(415) 322-5419A.611Quality Assurance Associate Carolina CoPackingQuality Assurance AssociateHenderson, North Carolinadiv class="careers-description__container">Quality Assurance Specialist. • Address and discuss issues and proposed solutions with all department management teams and Regulatory/Compliance Manager.QA Specialist, DSM (0600 1800/2 2 3) FUJIFILM Biotechnologies USA IncQA Specialist, DSM (0600 1800/2 2 3)Holly Springs, NCProvides QA oversight and supports DSM operations in accordance with governing processes and procedures• Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites. Minimum Requirements: BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR• Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience• 1-3 years' experience in a GMP environment• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.Sr. Quality Assurance Specialist - 3rd Shift Alcami CorporationSr. Quality Assurance Specialist - 3rd ShiftMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.Sr. Quality Assurance Specialist - 2nd Shift Alcami CorporationSr. Quality Assurance Specialist - 2nd ShiftMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.Sr. Quality Assurance Specialist Alcami CorporationSr. Quality Assurance SpecialistMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.Quality Assurance Specialist LancesoftQuality Assurance SpecialistResearch Triangle Park, NC$33Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical (GCLP guidelines) and preclinical studies (GLP regulations), qualification and/or validation of methods, laboratory processes, etc. Education/ Qualifications:Quality Assurance Specialist - Bachelor’s degree, in health care or relevant scientific field and 3+ years of relevant industry experience.Sr. Quality Assurance Specialist AskBioSr. Quality Assurance SpecialistDurham, North CarolinaThe company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. This key individual performs vendor assessments and occasional audits (virtual and on-site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations.Principal QA Specialist KBI Biopharma IncPrincipal QA SpecialistDurham, NCp>Demonstrated solid Body of Knowledge of Quality systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus. Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results Able to navigate conflict to achieve deliverables and drive to targeted outcomes Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people Voluntarily communicates needs and suggestions clearly and effectively Listens and is attentive to others' ideas and contributions.QA Specialist, Warehouse (Supply Chain) FUJIFILM Biotechnologies USA IncQA Specialist, Warehouse (Supply Chain)Holly Springs, NCAll resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).Quality Assurance Specialist 2 Veranex IncQuality Assurance Specialist 2Raleigh, NCAs the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. What You Will Do: Perform day‑to‑day maintenance and administration of the QMS, including eQMS data entry, document updates, records management, monitoring system due dates, and responding to quality‑related requests from staff and project teams.Sr. Quality Assurance Specialist AskBio IncSr. Quality Assurance SpecialistDurham, NCThe company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinsons disease, and Pompe disease. This key individual performs vendor assessments and occasional audits (virtual and on-site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations.KBI: US - QA Specialist II KBI Biopharma IncKBI: US - QA Specialist IIDurham, NC$55,000–$86,900 / yearThis includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: Executed Batch record review and approval.Lead QA Engineer - Tax Product Development (SDET) BDO USA PCLead QA Engineer - Tax Product Development (SDET)NC$140,000–$210,000 / yearThe annual allocation to the ESOP is fully funded by BDO through investments in company stock and grants employees the chance to grow their wealth over time as their shares vest and grow in value with the firm's success, with no employee contributions. The Lead Engineer leads the development and execution of comprehensive test plans, while mentoring junior team members and collaborating with cross-functional teams to deliver high-quality solutions.Principal QA Specialist KBI BiopharmaPrincipal QA SpecialistDurham, North CarolinaIncludes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus. Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and Regulatory requirements.KBI: US - QA Specialist II KBI BiopharmaKBI: US - QA Specialist IIDurham, North CarolinaThis includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: Executed Batch record review and approval.NewQA Specialist II, Quality Operations (Combination Products) United Therapeutics CorpQA Specialist II, Quality Operations (Combination Products)NCp>The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus. Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging activities.NewSenior QA Specialist, Quality Operations (Combination Products) United TherapeuticsSenior QA Specialist, Quality Operations (Combination Products)Research Triangle Park, NCEscalate unresolved issues or concerns to Quality Management and affected area management + Participate in client meetings and projects as it relates to manufacturing, product scheduling, batch records, supply chain, etc. to support product pipelines + Support regulatory authority (FDA, MHRA, EMA, QP, etc.) inspections and internal audits, including documentation audit team, pre-audit facility inspections, etc Minimum Requirements + Bachelor’s Degree in a scientific or related technical discipline + 5+ years of relevant pharmaceutical industry experience in a cGMP regulated environment + Ability to work independently and part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines and work extended hours to support business needs + Able to work extended hours to support business needs, as applicable + Experience in review of batch records, production records, process control records + Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements + Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization + Ability to handle confidential company data, projects, information, etc. + Review GMP documentation, including logbooks, pest control, waterlogs, calibration and maintenance reports, temperature monitoring, batch records, protocols, etc., as it relates to Combination products for accuracy, completeness, and compliance with UT policies and procedures + Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging operations + Review and disposition manufacturing, packaging and Combination Products batch records and raw materials and components for clinical and commercial processes + Review of quality control final product and stability data + Process rejected lots of raw materials, components and Combination products identified for destruction.Senior QA Specialist Deviations and CAPAs KBI Biopharma IncSenior QA Specialist Deviations and CAPAsDurham, NCp>Job Responsibilities: Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Minimum Requirements: Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.Senior QA Specialist Deviations and CAPAs KBI BiopharmaSenior QA Specialist Deviations and CAPAsDurham, North Carolinap/>Job Responsibilities: Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Minimum Requirements: Minimum BS in scientific field with 14+ years’ experience or MS and 11+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.Technician - Process Quality Assurance Floor Support (Night Shift) Eli Lilly and CoTechnician - Process Quality Assurance Floor Support (Night Shift)Research Triangle Park, NC$18.02–$38.61 / hourOur current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise.QA Specialist II KBI BiopharmaQA Specialist IIDurham, North CarolinaIf any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization..Clinical Quality Assurance Specialist - Bone Marrow Transplant Program UNC HealthClinical Quality Assurance Specialist - Bone Marrow Transplant ProgramChapel Hill, NC$35.87–$51.57 / hourli>Collaborate with multidisciplinary teams to support performance improvement initiatives and ensures ongoing FACT accreditation readiness by maintaining audit preparedness, supporting inspections, and facilitating corrective action plans as needed. Promotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives.Quality Analyst 2 Garmin LtdQuality Analyst 2Cary, NCIn this role, you will be responsible for providing leadership of quality assurance activities for complex features within the Garmin Outdoor product websites, APIs, and software in a team-oriented environment. Overview We are seeking a full-time Quality Analyst 2 in our Cary, NC location.QA Lead Expert In Recruitment SolutionsQA LeadDurham, NCTwo (2) years' experience (cumulative) developing QA strategies, test plans, test cases, and metrics to measure quality and readiness. Collaborate with program management, business analysts, developers, and vendors to prioritize defect resolution and testing scope.Quality Analyst 2 Garmin International, Inc.Quality Analyst 2Cary, North Carolinaul>Demonstrate the role of quality assurance in each phase of the Software Development Life Cycle and/or Product Development Life Cycle and demonstrate knowledge of Garmin product specifications, capabilities and operation related to the market segment being supported. Must possess superior organizational/analytical skills, be detail oriented with the ability to prioritize and manage multiple tasks, can work independently with minimal supervision, and can exercise sound independent judgment.Quality Assurance Area Specialist III - QC Operational Readiness Novo Nordisk ASQuality Assurance Area Specialist III - QC Operational ReadinessClayton, NCDemonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments.Quality Assurance Area Specialist III Novo Nordisk ASQuality Assurance Area Specialist IIIClayton, NCli>Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments.Quality Assurance Area Specialist III - Finished Production Novo Nordisk ASQuality Assurance Area Specialist III - Finished ProductionClayton, NCli>Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Quality oversight, review & approval of validation activities and documents associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems.QA Validations Analyst Leadstack IncQA Validations AnalystResearch Triangle Park, NC$45–$54 / hourstrong> Job Responsibilities: The Validations Contractor GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance, will be responsible for ensuring the compliant onboarding, qualification, and validation of equipment, instruments, and computerized systems against corporate procedures, and applicable GMP national, international, and state regulations. Provide timely quality support and thorough reviews and approvals of various records including, but not limited to; equipment and computer system qualification and validation documents, SOPs, Change Controls, non-conformities, Deviations and Corrective Action/Preventive Action (CAPAs).Sr. Specialist I, Product Quality Assurance Beam Therapeutics IncSr. Specialist I, Product Quality AssuranceDurham, NC$140,000–$185,000 / yearBeams suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. The role will provide Quality oversight of routine manufacturing, testing, and related operations to ensure that systems and processes are maintained in compliance with Good Manufacturing Practices (GMP), and ultimately to Good Distribution Practices (GDP) as the programs move to the commercial phase.Coding Quality Assurance Auditor Novant Health IncCoding Quality Assurance AuditorNCp>The Coding Quality Assurance Auditor is part of Novant's RCS Coding team supporting patient care by driving accuracy and adherence to coding guidelines, governmental and private Third-Party rules, and regulations, to deliver the most remarkable patient experience, in every dimension, every time. Excellent verbal and written communication skills and the ability to effectively communicate with coding team members, providing positive constructive feedback from audit results.IT Quality Assurance Analyst II (Remote - NC, AZ, TX, FL) First Citizens BancShares IncIT Quality Assurance Analyst II (Remote - NC, AZ, TX, FL)NCRemoteAbility to own a user story from beginning to end by working across teams with Business partners to ensure User Acceptance testing reflects business processes and workflows and is completed. Ability to determine test data needs for SIT ensuring test data with respect to synthetic data requirements and omits any personal identification (PII) data from created test data.Quality Specialist III Precision Biosciences IncQuality Specialist IIIDurham, NCp>Required: Bachelors degree in Biology, Biochemistry, Chemistry, Microbiology, or a related life sciences discipline and 5+ years of relevant experience in a GMP-regulated environment, including background in quality assurance, research, or biopharmaceutical/gene therapy manufacturing, or equivalent combination of education and experience. The Quality Specialist III is responsible for providing dedicated quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations at Precision BioSciences, including batch release review, deviation assessment, and CDMO oversight.Quality Assurance Manager OnticQuality Assurance ManagerCreedmoor, North Carolinap style="text-align:left">Please click here to review Ontic's California Consumer Privacy Act policy.. Ontic is a leading global aerospace OEM trusted by the world’s aviation leaders.Senior Specialist, Quality Assurance Oxford BioMedica PlcSenior Specialist, Quality AssuranceDurham, NCp>OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. In this role, you will be responsible for overseeing all Facilities operations within an FDA-approved clinical cGMP manufacturing facility, playing a key part in advancing our mission and making a real difference.12345678910Similar Job SearchesQuality Manager JobsQuality Control Manager JobsManufacturing Manager JobsQuality Technician JobsQuality Specialist JobsDirector Of Quality JobsProduction Manager JobsQuality Assurance JobsQuality Assurance JobsQuality Assurance JobsStand out to leading employers.Upload your resume and let employers find you for new Quality Assurance job openings. Plus, receive relevant job matches delivered straight to your inbox.Send Us Your ResumeCreate A Free Account
Quality Assurance Associate Carolina CoPackingQuality Assurance AssociateHenderson, North Carolinadiv class="careers-description__container">Quality Assurance Specialist. • Address and discuss issues and proposed solutions with all department management teams and Regulatory/Compliance Manager.QA Specialist, DSM (0600 1800/2 2 3) FUJIFILM Biotechnologies USA IncQA Specialist, DSM (0600 1800/2 2 3)Holly Springs, NCProvides QA oversight and supports DSM operations in accordance with governing processes and procedures• Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites. Minimum Requirements: BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR• Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience• 1-3 years' experience in a GMP environment• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.Sr. Quality Assurance Specialist - 3rd Shift Alcami CorporationSr. Quality Assurance Specialist - 3rd ShiftMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.Sr. Quality Assurance Specialist - 2nd Shift Alcami CorporationSr. Quality Assurance Specialist - 2nd ShiftMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.Sr. Quality Assurance Specialist Alcami CorporationSr. Quality Assurance SpecialistMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.Quality Assurance Specialist LancesoftQuality Assurance SpecialistResearch Triangle Park, NC$33Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical (GCLP guidelines) and preclinical studies (GLP regulations), qualification and/or validation of methods, laboratory processes, etc. Education/ Qualifications:Quality Assurance Specialist - Bachelor’s degree, in health care or relevant scientific field and 3+ years of relevant industry experience.Sr. Quality Assurance Specialist AskBioSr. Quality Assurance SpecialistDurham, North CarolinaThe company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. This key individual performs vendor assessments and occasional audits (virtual and on-site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations.Principal QA Specialist KBI Biopharma IncPrincipal QA SpecialistDurham, NCp>Demonstrated solid Body of Knowledge of Quality systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus. Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results Able to navigate conflict to achieve deliverables and drive to targeted outcomes Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people Voluntarily communicates needs and suggestions clearly and effectively Listens and is attentive to others' ideas and contributions.QA Specialist, Warehouse (Supply Chain) FUJIFILM Biotechnologies USA IncQA Specialist, Warehouse (Supply Chain)Holly Springs, NCAll resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).Quality Assurance Specialist 2 Veranex IncQuality Assurance Specialist 2Raleigh, NCAs the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. What You Will Do: Perform day‑to‑day maintenance and administration of the QMS, including eQMS data entry, document updates, records management, monitoring system due dates, and responding to quality‑related requests from staff and project teams.Sr. Quality Assurance Specialist AskBio IncSr. Quality Assurance SpecialistDurham, NCThe company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinsons disease, and Pompe disease. This key individual performs vendor assessments and occasional audits (virtual and on-site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations.KBI: US - QA Specialist II KBI Biopharma IncKBI: US - QA Specialist IIDurham, NC$55,000–$86,900 / yearThis includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: Executed Batch record review and approval.Lead QA Engineer - Tax Product Development (SDET) BDO USA PCLead QA Engineer - Tax Product Development (SDET)NC$140,000–$210,000 / yearThe annual allocation to the ESOP is fully funded by BDO through investments in company stock and grants employees the chance to grow their wealth over time as their shares vest and grow in value with the firm's success, with no employee contributions. The Lead Engineer leads the development and execution of comprehensive test plans, while mentoring junior team members and collaborating with cross-functional teams to deliver high-quality solutions.Principal QA Specialist KBI BiopharmaPrincipal QA SpecialistDurham, North CarolinaIncludes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus. Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and Regulatory requirements.KBI: US - QA Specialist II KBI BiopharmaKBI: US - QA Specialist IIDurham, North CarolinaThis includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: Executed Batch record review and approval.NewQA Specialist II, Quality Operations (Combination Products) United Therapeutics CorpQA Specialist II, Quality Operations (Combination Products)NCp>The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus. Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging activities.NewSenior QA Specialist, Quality Operations (Combination Products) United TherapeuticsSenior QA Specialist, Quality Operations (Combination Products)Research Triangle Park, NCEscalate unresolved issues or concerns to Quality Management and affected area management + Participate in client meetings and projects as it relates to manufacturing, product scheduling, batch records, supply chain, etc. to support product pipelines + Support regulatory authority (FDA, MHRA, EMA, QP, etc.) inspections and internal audits, including documentation audit team, pre-audit facility inspections, etc Minimum Requirements + Bachelor’s Degree in a scientific or related technical discipline + 5+ years of relevant pharmaceutical industry experience in a cGMP regulated environment + Ability to work independently and part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines and work extended hours to support business needs + Able to work extended hours to support business needs, as applicable + Experience in review of batch records, production records, process control records + Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements + Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization + Ability to handle confidential company data, projects, information, etc. + Review GMP documentation, including logbooks, pest control, waterlogs, calibration and maintenance reports, temperature monitoring, batch records, protocols, etc., as it relates to Combination products for accuracy, completeness, and compliance with UT policies and procedures + Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging operations + Review and disposition manufacturing, packaging and Combination Products batch records and raw materials and components for clinical and commercial processes + Review of quality control final product and stability data + Process rejected lots of raw materials, components and Combination products identified for destruction.Senior QA Specialist Deviations and CAPAs KBI Biopharma IncSenior QA Specialist Deviations and CAPAsDurham, NCp>Job Responsibilities: Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Minimum Requirements: Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.Senior QA Specialist Deviations and CAPAs KBI BiopharmaSenior QA Specialist Deviations and CAPAsDurham, North Carolinap/>Job Responsibilities: Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Minimum Requirements: Minimum BS in scientific field with 14+ years’ experience or MS and 11+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.Technician - Process Quality Assurance Floor Support (Night Shift) Eli Lilly and CoTechnician - Process Quality Assurance Floor Support (Night Shift)Research Triangle Park, NC$18.02–$38.61 / hourOur current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise.QA Specialist II KBI BiopharmaQA Specialist IIDurham, North CarolinaIf any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization..Clinical Quality Assurance Specialist - Bone Marrow Transplant Program UNC HealthClinical Quality Assurance Specialist - Bone Marrow Transplant ProgramChapel Hill, NC$35.87–$51.57 / hourli>Collaborate with multidisciplinary teams to support performance improvement initiatives and ensures ongoing FACT accreditation readiness by maintaining audit preparedness, supporting inspections, and facilitating corrective action plans as needed. Promotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives.Quality Analyst 2 Garmin LtdQuality Analyst 2Cary, NCIn this role, you will be responsible for providing leadership of quality assurance activities for complex features within the Garmin Outdoor product websites, APIs, and software in a team-oriented environment. Overview We are seeking a full-time Quality Analyst 2 in our Cary, NC location.QA Lead Expert In Recruitment SolutionsQA LeadDurham, NCTwo (2) years' experience (cumulative) developing QA strategies, test plans, test cases, and metrics to measure quality and readiness. Collaborate with program management, business analysts, developers, and vendors to prioritize defect resolution and testing scope.Quality Analyst 2 Garmin International, Inc.Quality Analyst 2Cary, North Carolinaul>Demonstrate the role of quality assurance in each phase of the Software Development Life Cycle and/or Product Development Life Cycle and demonstrate knowledge of Garmin product specifications, capabilities and operation related to the market segment being supported. Must possess superior organizational/analytical skills, be detail oriented with the ability to prioritize and manage multiple tasks, can work independently with minimal supervision, and can exercise sound independent judgment.Quality Assurance Area Specialist III - QC Operational Readiness Novo Nordisk ASQuality Assurance Area Specialist III - QC Operational ReadinessClayton, NCDemonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments.Quality Assurance Area Specialist III Novo Nordisk ASQuality Assurance Area Specialist IIIClayton, NCli>Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments.Quality Assurance Area Specialist III - Finished Production Novo Nordisk ASQuality Assurance Area Specialist III - Finished ProductionClayton, NCli>Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Quality oversight, review & approval of validation activities and documents associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems.QA Validations Analyst Leadstack IncQA Validations AnalystResearch Triangle Park, NC$45–$54 / hourstrong> Job Responsibilities: The Validations Contractor GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance, will be responsible for ensuring the compliant onboarding, qualification, and validation of equipment, instruments, and computerized systems against corporate procedures, and applicable GMP national, international, and state regulations. Provide timely quality support and thorough reviews and approvals of various records including, but not limited to; equipment and computer system qualification and validation documents, SOPs, Change Controls, non-conformities, Deviations and Corrective Action/Preventive Action (CAPAs).Sr. Specialist I, Product Quality Assurance Beam Therapeutics IncSr. Specialist I, Product Quality AssuranceDurham, NC$140,000–$185,000 / yearBeams suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. The role will provide Quality oversight of routine manufacturing, testing, and related operations to ensure that systems and processes are maintained in compliance with Good Manufacturing Practices (GMP), and ultimately to Good Distribution Practices (GDP) as the programs move to the commercial phase.Coding Quality Assurance Auditor Novant Health IncCoding Quality Assurance AuditorNCp>The Coding Quality Assurance Auditor is part of Novant's RCS Coding team supporting patient care by driving accuracy and adherence to coding guidelines, governmental and private Third-Party rules, and regulations, to deliver the most remarkable patient experience, in every dimension, every time. Excellent verbal and written communication skills and the ability to effectively communicate with coding team members, providing positive constructive feedback from audit results.IT Quality Assurance Analyst II (Remote - NC, AZ, TX, FL) First Citizens BancShares IncIT Quality Assurance Analyst II (Remote - NC, AZ, TX, FL)NCRemoteAbility to own a user story from beginning to end by working across teams with Business partners to ensure User Acceptance testing reflects business processes and workflows and is completed. Ability to determine test data needs for SIT ensuring test data with respect to synthetic data requirements and omits any personal identification (PII) data from created test data.Quality Specialist III Precision Biosciences IncQuality Specialist IIIDurham, NCp>Required: Bachelors degree in Biology, Biochemistry, Chemistry, Microbiology, or a related life sciences discipline and 5+ years of relevant experience in a GMP-regulated environment, including background in quality assurance, research, or biopharmaceutical/gene therapy manufacturing, or equivalent combination of education and experience. The Quality Specialist III is responsible for providing dedicated quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations at Precision BioSciences, including batch release review, deviation assessment, and CDMO oversight.Quality Assurance Manager OnticQuality Assurance ManagerCreedmoor, North Carolinap style="text-align:left">Please click here to review Ontic's California Consumer Privacy Act policy.. Ontic is a leading global aerospace OEM trusted by the world’s aviation leaders.Senior Specialist, Quality Assurance Oxford BioMedica PlcSenior Specialist, Quality AssuranceDurham, NCp>OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. In this role, you will be responsible for overseeing all Facilities operations within an FDA-approved clinical cGMP manufacturing facility, playing a key part in advancing our mission and making a real difference.12345678910Similar Job SearchesQuality Manager JobsQuality Control Manager JobsManufacturing Manager JobsQuality Technician JobsQuality Specialist JobsDirector Of Quality JobsProduction Manager JobsQuality Assurance JobsQuality Assurance JobsQuality Assurance Jobs
QA Specialist, DSM (0600 1800/2 2 3) FUJIFILM Biotechnologies USA IncQA Specialist, DSM (0600 1800/2 2 3)Holly Springs, NCProvides QA oversight and supports DSM operations in accordance with governing processes and procedures• Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites. Minimum Requirements: BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR• Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience• 1-3 years' experience in a GMP environment• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
Sr. Quality Assurance Specialist - 3rd Shift Alcami CorporationSr. Quality Assurance Specialist - 3rd ShiftMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.
Sr. Quality Assurance Specialist - 2nd Shift Alcami CorporationSr. Quality Assurance Specialist - 2nd ShiftMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.
Sr. Quality Assurance Specialist Alcami CorporationSr. Quality Assurance SpecialistMorrisville, North Carolinap style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.
Quality Assurance Specialist LancesoftQuality Assurance SpecialistResearch Triangle Park, NC$33Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical (GCLP guidelines) and preclinical studies (GLP regulations), qualification and/or validation of methods, laboratory processes, etc. Education/ Qualifications:Quality Assurance Specialist - Bachelor’s degree, in health care or relevant scientific field and 3+ years of relevant industry experience.
Sr. Quality Assurance Specialist AskBioSr. Quality Assurance SpecialistDurham, North CarolinaThe company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. This key individual performs vendor assessments and occasional audits (virtual and on-site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations.
Principal QA Specialist KBI Biopharma IncPrincipal QA SpecialistDurham, NCp>Demonstrated solid Body of Knowledge of Quality systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus. Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results Able to navigate conflict to achieve deliverables and drive to targeted outcomes Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people Voluntarily communicates needs and suggestions clearly and effectively Listens and is attentive to others' ideas and contributions.
QA Specialist, Warehouse (Supply Chain) FUJIFILM Biotechnologies USA IncQA Specialist, Warehouse (Supply Chain)Holly Springs, NCAll resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
Quality Assurance Specialist 2 Veranex IncQuality Assurance Specialist 2Raleigh, NCAs the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. What You Will Do: Perform day‑to‑day maintenance and administration of the QMS, including eQMS data entry, document updates, records management, monitoring system due dates, and responding to quality‑related requests from staff and project teams.
Sr. Quality Assurance Specialist AskBio IncSr. Quality Assurance SpecialistDurham, NCThe company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinsons disease, and Pompe disease. This key individual performs vendor assessments and occasional audits (virtual and on-site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations.
KBI: US - QA Specialist II KBI Biopharma IncKBI: US - QA Specialist IIDurham, NC$55,000–$86,900 / yearThis includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: Executed Batch record review and approval.
Lead QA Engineer - Tax Product Development (SDET) BDO USA PCLead QA Engineer - Tax Product Development (SDET)NC$140,000–$210,000 / yearThe annual allocation to the ESOP is fully funded by BDO through investments in company stock and grants employees the chance to grow their wealth over time as their shares vest and grow in value with the firm's success, with no employee contributions. The Lead Engineer leads the development and execution of comprehensive test plans, while mentoring junior team members and collaborating with cross-functional teams to deliver high-quality solutions.
Principal QA Specialist KBI BiopharmaPrincipal QA SpecialistDurham, North CarolinaIncludes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus. Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and Regulatory requirements.
KBI: US - QA Specialist II KBI BiopharmaKBI: US - QA Specialist IIDurham, North CarolinaThis includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: Executed Batch record review and approval.
NewQA Specialist II, Quality Operations (Combination Products) United Therapeutics CorpQA Specialist II, Quality Operations (Combination Products)NCp>The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus. Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging activities.
NewSenior QA Specialist, Quality Operations (Combination Products) United TherapeuticsSenior QA Specialist, Quality Operations (Combination Products)Research Triangle Park, NCEscalate unresolved issues or concerns to Quality Management and affected area management + Participate in client meetings and projects as it relates to manufacturing, product scheduling, batch records, supply chain, etc. to support product pipelines + Support regulatory authority (FDA, MHRA, EMA, QP, etc.) inspections and internal audits, including documentation audit team, pre-audit facility inspections, etc Minimum Requirements + Bachelor’s Degree in a scientific or related technical discipline + 5+ years of relevant pharmaceutical industry experience in a cGMP regulated environment + Ability to work independently and part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines and work extended hours to support business needs + Able to work extended hours to support business needs, as applicable + Experience in review of batch records, production records, process control records + Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements + Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization + Ability to handle confidential company data, projects, information, etc. + Review GMP documentation, including logbooks, pest control, waterlogs, calibration and maintenance reports, temperature monitoring, batch records, protocols, etc., as it relates to Combination products for accuracy, completeness, and compliance with UT policies and procedures + Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging operations + Review and disposition manufacturing, packaging and Combination Products batch records and raw materials and components for clinical and commercial processes + Review of quality control final product and stability data + Process rejected lots of raw materials, components and Combination products identified for destruction.
Senior QA Specialist Deviations and CAPAs KBI Biopharma IncSenior QA Specialist Deviations and CAPAsDurham, NCp>Job Responsibilities: Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Minimum Requirements: Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
Senior QA Specialist Deviations and CAPAs KBI BiopharmaSenior QA Specialist Deviations and CAPAsDurham, North Carolinap/>Job Responsibilities: Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Minimum Requirements: Minimum BS in scientific field with 14+ years’ experience or MS and 11+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
Technician - Process Quality Assurance Floor Support (Night Shift) Eli Lilly and CoTechnician - Process Quality Assurance Floor Support (Night Shift)Research Triangle Park, NC$18.02–$38.61 / hourOur current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise.
QA Specialist II KBI BiopharmaQA Specialist IIDurham, North CarolinaIf any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization..
Clinical Quality Assurance Specialist - Bone Marrow Transplant Program UNC HealthClinical Quality Assurance Specialist - Bone Marrow Transplant ProgramChapel Hill, NC$35.87–$51.57 / hourli>Collaborate with multidisciplinary teams to support performance improvement initiatives and ensures ongoing FACT accreditation readiness by maintaining audit preparedness, supporting inspections, and facilitating corrective action plans as needed. Promotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives.
Quality Analyst 2 Garmin LtdQuality Analyst 2Cary, NCIn this role, you will be responsible for providing leadership of quality assurance activities for complex features within the Garmin Outdoor product websites, APIs, and software in a team-oriented environment. Overview We are seeking a full-time Quality Analyst 2 in our Cary, NC location.
QA Lead Expert In Recruitment SolutionsQA LeadDurham, NCTwo (2) years' experience (cumulative) developing QA strategies, test plans, test cases, and metrics to measure quality and readiness. Collaborate with program management, business analysts, developers, and vendors to prioritize defect resolution and testing scope.
Quality Analyst 2 Garmin International, Inc.Quality Analyst 2Cary, North Carolinaul>Demonstrate the role of quality assurance in each phase of the Software Development Life Cycle and/or Product Development Life Cycle and demonstrate knowledge of Garmin product specifications, capabilities and operation related to the market segment being supported. Must possess superior organizational/analytical skills, be detail oriented with the ability to prioritize and manage multiple tasks, can work independently with minimal supervision, and can exercise sound independent judgment.
Quality Assurance Area Specialist III - QC Operational Readiness Novo Nordisk ASQuality Assurance Area Specialist III - QC Operational ReadinessClayton, NCDemonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments.
Quality Assurance Area Specialist III Novo Nordisk ASQuality Assurance Area Specialist IIIClayton, NCli>Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments.
Quality Assurance Area Specialist III - Finished Production Novo Nordisk ASQuality Assurance Area Specialist III - Finished ProductionClayton, NCli>Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred. Quality oversight, review & approval of validation activities and documents associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems.
QA Validations Analyst Leadstack IncQA Validations AnalystResearch Triangle Park, NC$45–$54 / hourstrong> Job Responsibilities: The Validations Contractor GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance, will be responsible for ensuring the compliant onboarding, qualification, and validation of equipment, instruments, and computerized systems against corporate procedures, and applicable GMP national, international, and state regulations. Provide timely quality support and thorough reviews and approvals of various records including, but not limited to; equipment and computer system qualification and validation documents, SOPs, Change Controls, non-conformities, Deviations and Corrective Action/Preventive Action (CAPAs).
Sr. Specialist I, Product Quality Assurance Beam Therapeutics IncSr. Specialist I, Product Quality AssuranceDurham, NC$140,000–$185,000 / yearBeams suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. The role will provide Quality oversight of routine manufacturing, testing, and related operations to ensure that systems and processes are maintained in compliance with Good Manufacturing Practices (GMP), and ultimately to Good Distribution Practices (GDP) as the programs move to the commercial phase.
Coding Quality Assurance Auditor Novant Health IncCoding Quality Assurance AuditorNCp>The Coding Quality Assurance Auditor is part of Novant's RCS Coding team supporting patient care by driving accuracy and adherence to coding guidelines, governmental and private Third-Party rules, and regulations, to deliver the most remarkable patient experience, in every dimension, every time. Excellent verbal and written communication skills and the ability to effectively communicate with coding team members, providing positive constructive feedback from audit results.
IT Quality Assurance Analyst II (Remote - NC, AZ, TX, FL) First Citizens BancShares IncIT Quality Assurance Analyst II (Remote - NC, AZ, TX, FL)NCRemoteAbility to own a user story from beginning to end by working across teams with Business partners to ensure User Acceptance testing reflects business processes and workflows and is completed. Ability to determine test data needs for SIT ensuring test data with respect to synthetic data requirements and omits any personal identification (PII) data from created test data.
Quality Specialist III Precision Biosciences IncQuality Specialist IIIDurham, NCp>Required: Bachelors degree in Biology, Biochemistry, Chemistry, Microbiology, or a related life sciences discipline and 5+ years of relevant experience in a GMP-regulated environment, including background in quality assurance, research, or biopharmaceutical/gene therapy manufacturing, or equivalent combination of education and experience. The Quality Specialist III is responsible for providing dedicated quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations at Precision BioSciences, including batch release review, deviation assessment, and CDMO oversight.
Quality Assurance Manager OnticQuality Assurance ManagerCreedmoor, North Carolinap style="text-align:left">Please click here to review Ontic's California Consumer Privacy Act policy.. Ontic is a leading global aerospace OEM trusted by the world’s aviation leaders.
Senior Specialist, Quality Assurance Oxford BioMedica PlcSenior Specialist, Quality AssuranceDurham, NCp>OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. In this role, you will be responsible for overseeing all Facilities operations within an FDA-approved clinical cGMP manufacturing facility, playing a key part in advancing our mission and making a real difference.