Senior QA Specialist - cGMP Compliance & Ops
Oxford Biomedica
Oxford Biomedica in Durham, North Carolina is seeking a Quality Assurance Senior Specialist to oversee operations in an FDA-approved clinical cGMP manufacturing facility. This role is critical in ensuring compliance and advancing our mission of delivering life-changing therapies. The ideal candidate will have a strong background in quality assurance, with over 7 years of experience in the pharmaceutical industry, including 3 years in Quality management. Key responsibilities include documenting compliance, managing quality events, and preparing for inspections. #J-18808-Ljbffr Oxford Biomedica
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- ...experienced Quality Assurance professional. The role involves providing QA support to manufacturing processes, reviewing, and approving... ...have a Bachelor's degree and over 8 years of experience in a QA cGMP environment. The company fosters an inclusive work culture and...Senior
- ...involves collaborating with various departments to resolve compliance issues and providing mentorship to junior QA staff. The ideal candidate will possess a scientific degree and substantial experience in a QA cGMP regulated environment, emphasizing a strong grasp of...Senior
- ...pharmaceutical company in North Carolina seeks a Production Director. This role involves providing leadership and direction to cGMP manufacturing, ensuring compliance, operational efficiency, and the successful delivery of client projects. The ideal candidate will have over 8 years...Senior
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- Senior QA Specialist Deviations and CAPAs page is loaded## Senior QA Specialist Deviations and CAPAslocations... ...related deviations and other compliance issues in a timely manner. Review and... ...MS and 11+ years’ experience in a QA cGMP regulated environment within...SeniorImmediate start
- ...our Bioprocess Innovation Center to our cGMP‑compliant manufacturing site, we thrive on... ...Description Major Accountabilities Provides QA oversight and support for project... ...including risk and impact assessments do compliance data review, qualification protocols, validation...
$113k - $156k
KBI Biopharma Inc. in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. You will provide QA... ...of experience or a Master’s with 6+ years in a QA or cGMP environment. Salary ranges from $113,000 to $156,000, reflecting...- ...differential.Job SummaryThe QA Manufacturing Specialist is responsible for ensuring... ...supporting all aspects of cGMP operations. Client and regulatory... ...on-the-floor compliance review on executed records... ...equivalent is required.MQA Senior Specialist: BS/BA degree in...SeniorWork at officeImmediate startShift workNight shift
- Alcami Corporation in Morrisville is seeking a Senior Quality Assurance Specialist. This role is responsible for ensuring quality and compliance with regulatory requirements and will include activities such as performing internal audits, maintaining quality databases, and...SeniorFull timeAfternoon shift
- Precision BioSciences, Inc in Durham, NC is seeking a Quality Specialist III to provide dedicated quality assurance support for Chemistry... ...releases, performing deviation assessments, and ensuring compliance with regulatory standards. The ideal candidate will have a Bachelor...Senior
- Beam Therapeutics is looking for a Sr. Specialist I in NC Product Quality Assurance to oversee laboratory and manufacturing operations... ...requires daily on-site presence with a flexible schedule to ensure compliance with Good Manufacturing Practices. #J-18808-Ljbffr Beam...SeniorFlexible hours
- ALOIS Solutions is seeking a Quality Assurance Specialist based in Durham, NC. The role involves managing the Quality Management System (QMS), ensuring compliance with GMP regulations, and providing support for QMS-related requests. The ideal candidate will have a Bachelor...
- Join Novo Nordisk in Durham, NC as a Quality Assurance professional, responsible for ensuring compliance with regulations and quality processes. This role involves reviewing documentation, supporting investigations, and conducting audits to maintain high-quality standards...
- LeadStack Inc. is seeking a Quality Assurance Specialist to ensure corporate compliance with GMP standards. Located in Research Triangle Park, NC, this role entails managing QA responsibilities and supporting product quality systems. The ideal candidate will hold a Bachelor...Contract work
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- KBI Biopharma, Inc. is seeking an individual contributor for a Quality Assurance role focused on compliance with regulatory guidelines. This position involves interfacing with clients regarding batch status, managing quality issues, and ensuring systems are effective and...
- ...seeking a Quality Assurance professional responsible for ensuring compliance with regulations and quality standards. The role involves... ...candidate will hold an Associate’s degree, have at least two years of QA experience, and possess general knowledge of pharmaceutical...
- ...Durham, NC is seeking a Quality Assurance professional to ensure compliance with strict pharmaceutical regulations and operational standards... ...degree in life sciences and at least two years of experience in QA, alongside expert communication and documentation skills. This...
- Fujifilm Corporation is seeking a Quality Assurance Specialist in Durham, North Carolina. This role involves oversight of QA for project deliverables, ensuring compliance with QC laboratory processes, and fostering collaboration across teams. The ideal candidate holds...
- ...is looking for a qualified individual to oversee the compliance review of biopharmaceutical development GMP data.... ...regulated environment, along with substantial experience in QA data review, knowledge of USP, EU, and JP cGMP guidelines, and excellent analytical skills. #J-188...Senior
- KBI Biopharma Inc. is seeking a Principal Quality Compliance Specialist in Durham, NC. This role involves reviewing and approving deviations and... ...should have a minimum of 14 years' experience in a QA cGMP regulated environment, with a comprehensive understanding of...Senior
- ...involves providing technical support for ongoing operations and serving as a system owner for facilities automation systems, ensuring compliance with engineering and quality standards. This position requires extensive experience in automation and controls, with project...Senior
- ...opportunities to join us. We’re currently recruiting for a Senior QA Specialist, Compliance and Supplier Quality to join our team. In this role, you... ...in biotechnology industry preferred. Strong knowledge of cGMP in the Pharma/Biotech industry to include FDA, EU, JP regulatory...SeniorRemote work
$113k - $156k
...This individual is responsible for the compliance review of Biopharmaceutical GMP data. This... ...and stability test data. The Principal QA Specialist provides QA oversight of analytical and... ...comply with required procedures, cGLP, and cGMP requirements. Review and approve method...- ...Durham, NC, is seeking a highly skilled Process Engineer to support cGMP operations, ensuring that manufacturing process equipment is... ...and implement new processing equipment while ensuring compliance with all regulations. The ideal candidate has a Bachelor's in chemical...Senior
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