NewClinical Nurse Specialist (CNS Certified) - Cardiac Stepdown Duke HealthClinical Nurse Specialist (CNS Certified) - Cardiac StepdownDurham, NCThe Cardiac Stepdown Clinical Nurse Specialist collaborates with members of the healthcare team to enhance care for patients within the DUH Heart Center by serving as an expert resource and consultant to nursing staff and providing evidence-based clinical expertise to patients. Prescribes nursing therapeutics, interventions, diagnostic measures, equipment, procedures, and treatments to meet the needs of patients, families and groups, in accordance with professional preparation, institutional policy, state and federal laws and practice acts.
NewCommercial Real Estate Loan Specialist First Horizon BankCommercial Real Estate Loan SpecialistRaleigh, NCThe Pro CRE Loan Specialist position is a specialized position responsible for reviewing and understanding the Commercial Real Estate Loan approval/request, providing thorough, objective analysis of the Loan closing, construction documentation and funding requirements in the RE loan documents, and all supporting documentation required for closing, and confirming that the loan documents provide that the loan is being closed as required by the approval. Headquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services.
NewMedical Lab Specialist - Microbiology Laboratory UNC HealthMedical Lab Specialist - Microbiology LaboratoryChapel Hill, NC$31.04–$44.62 / hourThe Specialist works in collaboration with the laboratory supervisor and laboratory directors to address analytical problems and maintain scientific oversight of routine patient testing. The Microbiology Laboratory is currently recruiting a Medical Laboratory Specialist for the Central Processing, Bacteriology, and Special Microbiology areas of the laboratory.
Cardiovascular Specialist - Rex Invasive Heart & Vascular UNC HealthCardiovascular Specialist - Rex Invasive Heart & VascularRaleigh, NC$33.04–$47.50 / hourOperates multichannel physiologic monitor to measure and record functions of cardiovascular and pulmonary systems of patient during cardiac catherization. Learn more about the incentive program here: https://jobs.unchealthcare.org/pages/imaging-commitment-incentive-program.
NewClinical Dietitian - Outpatient Pediatric Duke HealthClinical Dietitian - Outpatient PediatricDurham, NCThese areas include: Student Advisor, Malnutrition Specialist, Adult Nutrition Support Specialist, Pediatric Nutrition Support Specialist, Program Coordinator, Clinical and Quality Specialist, IT Specialist, Outpatient Clinical Coordinator, Lead, Subject Matter Expert. The Duke University Hospital delivers patient centered care and is known for expertise in Inpatient, Urgent Outpatient, OR, Interventional, ED/Trauma, PEDS, Cardiac, Oncology, and Transplant services.
Communication Specialist IV - (Account Manager & Creative Project Manager) # 26-13303 US Tech SolutionsCommunication Specialist IV - (Account Manager & Creative Project Manager) # 26-13303Raleigh, NC$40–$55 / hourContractorFull timeThe Communications Consultant – Account Managers are responsible for managing the development and execution of all communications projects for customer work to ensure message and brand consistency and align with corporate strategies. Work with key clients and the External Digital Communications Channels team to improve the company’s online marketing channels and ensure processes are followed.
Sr. Quality Systems Specialist, Quality Operational Readiness (QOR) Grifols SASr. Quality Systems Specialist, Quality Operational Readiness (QOR)Clayton, NCQuality Systems Specialist will work in the framework of cross-functional quality teams, including Subject Matter Experts (SMEs), and collaborate closely with Grifols BioPharma sites Engineering, Manufacturing, Regulatory Affairs, IT, and Global Quality to establish robust quality systems and processes aligned with cGMP and global health authority expectations. BS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 7 years relevant experience OR an equivilant combination of education and experience.
NewQuality Specialist - 1st Shift - RPO Eaton Corporation PlcQuality Specialist - 1st Shift - RPORaleigh, NCAfter making a conditional offer and running a background check, if Eaton is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. In this function you will: Assist in quality audits, workmanship defect reduction efforts, corrective and preventive action identification, analysis and reporting, inspection of returned units, special inspections.
NewQA Specialist II, Quality Operations (Combination Products) United Therapeutics CorpQA Specialist II, Quality Operations (Combination Products)NCPerform 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. 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.
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.
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 Specialist - Medicare D Quality CVS Health CorpQuality Specialist - Medicare D QualityWork At Home, NC$18.50–$42.35 / hourOur teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong. Quality Specialist- Medicare D Quality role administers the quality management system to manage the review of clinical processes, documentation, and patient records.
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.
Senior QA Specialist, QA for QC (CVRM) GenentechSenior QA Specialist, QA for QC (CVRM)Holly Springs, North CarolinaYou will partner directly with the QC department to provide day-to-day quality compliance support, serving as a trusted gatekeeper for data integrity, support investigations and manage change controls related to laboratory systems, test methods, and digital applications, ensuring modifications do not compromise the validated state of our operations. This position is a unique opportunity to embed quality into the site's operational design, support a continuous improvement culture, and drive operational excellence in accordance with Good Manufacturing Practices, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.
Advanced Practice Provider (NP/PA) - Clinical Quality Specialist I Avance CareAdvanced Practice Provider (NP/PA) - Clinical Quality Specialist IDurham, North Carolinap style="margin:0px">Avance Care is seeking an experienced Advanced Practice Provider (Nurse Practitioner or Physician Assistant) for an exciting opportunity to grow your career in a role that offers both meaningful patient connection and broader organizational impact. If you’re looking for a role where you can care for patients, influence meaningful change, and grow as a clinical leader, we invite you to join Avance Care and be part of the future of high-quality, data-driven healthcare.
Quality Specialist III Precision Biosciences IncQuality Specialist IIIDurham, NCRequired: 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.
Senior QA Specialist Deviations and CAPAs KBI Biopharma IncSenior QA Specialist Deviations and CAPAsDurham, NCJob 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.
Sr. Quality Specialist - cGMP Manufacturing - Weekend 1st Shift Alcami CorporationSr. Quality Specialist - cGMP Manufacturing - Weekend 1st 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.
Quality Assurance Area Specialist III (QA for Warehouse & Logistics) Novo Nordisk ASQuality Assurance Area Specialist III (QA for Warehouse & Logistics)Clayton, 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 (QA for Utilities) Novo Nordisk ASQuality Assurance Area Specialist III (QA for Utilities)Clayton, 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 - QA IT / Utilities Novo Nordisk ASQuality Assurance Area Specialist III - QA IT / UtilitiesClayton, 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 Specialist III Precision BiosciencesQuality Specialist IIIDurham, NCp/>Required: Bachelor’s 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.
NewQA Specialist (Hybrid) Eisai IncQA Specialist (Hybrid)Raleigh, NC$66,200–$86,800 / yearE-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. The QA Specialist, External Manufacturing Quality Operations (EMQO) supports Quality Assurance activities at the Eisai Raleigh facility by assisting with routine operational quality tasks under direction and supervision.
NewQA Specialist (Hybrid) EisaiQA Specialist (Hybrid)Raleigh, North CarolinaE-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. The QA Specialist, External Manufacturing Quality Operations (EMQO) supports Quality Assurance activities at the Eisai Raleigh facility by assisting with routine operational quality tasks under direction and supervision.
Principal QA Specialist KBI Biopharma IncPrincipal QA SpecialistDurham, NCDemonstrated 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.
Clinical QA Systems and Documentation Specialist Grifols SAClinical QA Systems and Documentation SpecialistNCExample: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department.
Senior QA Specialist Deviations and CAPAs KBI BiopharmaSenior QA Specialist Deviations and CAPAsDurham, North CarolinaJob 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.
NewSpecialist, Quality Systems & Compliance Merck & Co IncSpecialist, Quality Systems & ComplianceDurham, NC$71,900–$113,200 / yearPartnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee).
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.
Supplier Quality Specialist Guerbet SASupplier Quality 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. Provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials, consumables, external laboratories, and transportation providers.
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).
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.
Senior Quality Specialist CVS Health CorpSenior Quality SpecialistWork At Home-North Carolina, NC$18.50–$38.82 / hourActs as an advocate and subject matter expert guiding the business by serving as a quality champion through measuring and monitoring the quality and effectiveness of work processes in claim processing and customer service that impact customer satisfaction, medical cost management, and operational efficiency. Acts as a subject matter expert on Quality Specialist workflows, policies, systems requirements, and enhancements as well as daily operations and programs to consistently drive optimal results.
Quality Systems Improvement Specialist Guerbet SAQuality Systems Improvement 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. Working cross-functionally with Quality, Operations, and other stakeholders, the Specialist ensures quality systems are robust, compliant, and effectively embedded across the organization.
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.
NewQuality System Specialist II Becton Dickinson and CoQuality System Specialist IIDurham, NCThis person must be able to lead the end to end process of customer complaints, including utilization of the database systems used to process complaints, and will be responsible for processing of customer complaints specifically Medical Device Reports (MDR's), and complaint reports. Provides Education: Provides ongoing education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements and initial and ongoing assessment.
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.
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.
Senior Air Quality Specialist Anchor QEA LLCSenior Air Quality SpecialistRaleigh, NCResponsibilities include: preparing and providing technical quality control for environmental documents and permit applications developing and executing dispersion modeling approaches and protocols preparing emissions inventories, health risk evaluations (as applicable), and compliance analyses mentoring staff and coordinating and reviewing technical work across project phases developing task scopes, budgets, and schedules, and supporting proposal and marketing efforts when requested helping project managers to integrate air quality strategy into broader project planning and environmental compliance frameworks, including beginning to advise project teams and clients on regulatory interpretation and risk considerations and serving as a technical resource where appropriate in client and agency interactions. A senior-level environmental planner at Anchor QEA can expect: Strategic, impact-focused role, shaping project approaches and outcomes Highly supportive environment as part of multi-disciplinary, collaborative teams Opportunities for client and agency interaction, helping to guide key decision makers Contribution to business development strategies emphasizing valued relationships Strong emphasis on professional development for technical and leadership growth Culture of flexibility and accountability with an emphasis on work-life balance.
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.
Quality Administrative Specialist, Eurofins Built Environment Testing, Remote Eurofins Scientific SEQuality Administrative Specialist, Eurofins Built Environment Testing, RemoteRaleigh, NCRemote$22–$25 / hourp>Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base compensation may vary based upon, but not limited to, relevant experience and skill set, base compensation of internal peers, business sector, and geographic location. With climate change posing an imminent threat, Eurofins and its many companies recognize their duty to proactively reduce or offset the environmental impact of essential operations while also helping our clients do the same-serving as a true ESG Enabler.
Quality Risk Specialist Grifols SAQuality Risk SpecialistResearch Triangle Park, NCThe role plays a critical part in ensuring sustained compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and Grifols Quality Systems by proactively analyzing, interpreting, and monitoring quality data, key metrics, and associated systems. Ability to successfully interface with all levels of management and customers or suppliers in various functions to ensure well documented, factually supported analyses of issues related to supplier, test lab, warehouse logistics and plasma platform quality.
Quality Specialist - cGMP Manufacturing - Weekend 1st Shift Alcami CorporationQuality Specialist - cGMP Manufacturing - Weekend 1st ShiftMorrisville, North CarolinaJob Summary: The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed.
Quality Analytics Specialist Grifols SAQuality Analytics SpecialistNCSummary: Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems through the participation in management, analysis and monitoring of quality data and metrics and associated quality systems. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department.
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.
Quality Specialist Becton Dickinson and CoQuality SpecialistFour Oaks, NCProvide mentorship and guidance to North America regional teams on QMS requirements, including Nonconformance, Planned Deviations, and Audit processes, while actively contributing to continuous improvement initiativesLead and facilitate monthly North America Region Nonconformance Coach meetings to promote consistency, knowledge sharing, and effective issue resolution. May serve as a Regional Site CAPA Lead for the North America region, providing leadership and hands-on support for CAPA activities, including investigation management, root cause analysis (RCA), and development and execution of corrective and preventive action plans.
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.
Quality Assurance Specialist II Leadstack IncQuality Assurance Specialist IIResearch Triangle Park, NC$34–$34 / 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. Key Responsibilities:Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of AskBio laboratories.
NewQuality Training Specialist Guerbet SAQuality Training 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. This role partners with cross‑functional teams to drive training effectiveness, promote a culture of quality, and support continuous improvement through effective knowledge transfer and performance readiness.