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.
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.
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.
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.
QA 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.
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.
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.
QA 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.
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.
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 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.
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.
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.
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.
Customer Quality Specialist ABBCustomer Quality SpecialistMebane, North CarolinaMinimum 5 years relevant work experience in Incoterms knowledge, customer experience success, project execution, and supply chain, OR Associate degree in Engineering or related field PLUS minimum 7 years relevant work experience OR High School Diploma/GED PLUS 9 years of relevant work experience. In this role, you will have the opportunity to support the deployment of the quality strategy for a local organizational unit, including quality culture, systems, tools, and competent teams with the aim to achieve and exceed customer expectations, while ensuring sustainable operations.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Senior Specialist, Quality Risk & Governance Amgen IncSenior Specialist, Quality Risk & GovernanceNCp>In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
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.
Electrical Quality Specialist Adams Electric CompanyElectrical Quality SpecialistRaleigh, NCPerform all daily inspection and test of the scope and character necessary to achieve the quality of electrical construction required in the drawings and specifications for all works under the contract performed ON or OFF site. Requires familiarity in the use of computers and software packages needed to support the documentation, analysis and retention of quality records.
Quality Control Senior Specialist Actalent IncQuality Control Senior SpecialistHolly Springs, NC$45–$55 / hourOperating within the QC Systems group and reporting to the Manager of Digital Laboratory Systems, this role partners closely with QC subject matter experts to analyze workflows, identify inefficiencies, and build scalable digital solutions that enhance data accessibility, reporting, and operational efficiency. Doctorate degree and 2 years of experience, or Master's degree and 6 years of experience, or Bachelor's degree and 8 years of experience, or Associate degree and 10 years of experience, or high school diploma / GED and 12 years of experience.
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.
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.
Manufacturing Quality Tester ABBManufacturing Quality TesterMebane, North CarolinaAcross multiple energy-intensive industries, the business provides customers with end-to-end product and service solutions that help ensure the reliability and protection of their electrical infrastructure. ABB ELSP empowers smarter business operations by connecting equipment, software, and services to protect, control, and optimize assets within electrical infrastructures.
NewInspector - Quality Control TriceHealthcareInspector - Quality ControlRaleigh, NCIn 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 . • Initiate, participate in and/or coordinate internal 8D corrective actions (CARs), Failure Effect Mode Analysis, and Control Planning to include follow-up of vendor 8D corrective actions .
Manager, Quality Risk Grifols SAManager, Quality RiskNCp>Summary: Supervises a team of Quality Risk specialists and is responsible for ensuring organizational adherence to corporate quality processes, including quality management systems reviews, deviation/CAPA management, data integrity assessments, and risk management assessments. Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems through the management, analysis, and monitoring of quality data and metrics and associated quality systems to ensure a holistic and complete input to Biomat USA Quality systems.
Business Process Quality Senior Professional HitachiBusiness Process Quality Senior ProfessionalRaleigh, North CarolinaA previous hands-on experience in an electro-mechanical or related industry on a role as Quality Engineer or Specialist Expertise on the delivery of effective and accurate problem solving with solid Root Cause Analysis using different methodologies. Within the North American Hub in the Transformers Business Unit, we have a vast product portfolio consisting of Power, Distribution, Dry transformers, alongside components such as bushings and tap changers.
Document Control Specialist Thermo Fisher Scientific IncDocument Control SpecialistMorrisville, NCAs a Quality Specialist III, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner, and safer. The Document Control Specialist is responsible for managing and optimizing document control processes within the MasterControl Quality Management System (QMS).