Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 15 hours ago
Similar jobs that could be interesting for youBased on the Senior QA Specialist - cGMP Compliance & Ops in Durham, NC vacancy
  • OXB is seeking a Senior Specialist in Quality Assurance based in Durham, NC. In this role, you will be responsible for overseeing the compliance within an FDA-approved facility and ensuring quality...  ...along with a strong background in cGMP and quality assurance practices.... 
    Senior

    OXB

    Durham, NC
    1 day ago
  •  ...seeking a qualified candidate for a position responsible for the compliance review of biopharmaceutical development GMP data. This includes...  ...a BS with 11+ years or MS with 8+ years of experience in a CGMP-regulated environment, alongside strong analytical skills and familiarity... 
    Senior

    KBI Biopharma

    Durham, NC
    1 day ago
  • KBI Biopharma in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. This role includes reviewing...  ...in a QA/QC environment. Strong understanding of FDA and cGMP regulations is required. #J-18808-Ljbffr KBI Biopharma
    Senior

    KBI Biopharma

    Durham, NC
    2 days ago
  •  ...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

    Insight Global

    Durham, NC
    15 hours ago
  •  ...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

    KBI Biopharma, Inc.

    Durham, NC
    1 day ago
  •  ...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

    MedPharm

    Durham, NC
    5 days ago
  • Oxfordbiom in Durham, North Carolina is seeking a Quality Assurance Senior Specialist. This role involves overseeing operations within an FDA-approved clinical cGMP manufacturing facility and managing compliance to support life-changing therapies. The ideal candidate has 7+... 
    Senior

    Oxfordbiom

    Durham, NC
    4 days ago
  • A global life sciences provider is seeking a Senior Specialist in Quality Assurance at their Morrisville, North Carolina location. This role provides crucial on-site QA support to laboratory teams, ensuring compliance with GMP standards and documentation practices. The... 
    Senior

    Solvias

    Morrisville, NC
    3 days ago
  • 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... 
    Senior
    Immediate start

    KBI Biopharma Inc.

    Durham, NC
    4 days ago
  •  ...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... 

    Fujifilm Corporation

    Durham, NC
    15 hours ago
  • $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... 

    KBI Biopharma Inc.

    Durham, NC
    3 days ago
  •  ...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... 
    Senior
    Work at office
    Immediate start
    Shift work
    Night shift

    KBI Biopharma

    Durham, NC
    4 days ago
  • 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... 
    Senior
    Full time
    Afternoon shift

    Alcami Corporation

    Morrisville, NC
    1 day ago
  • 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

    Precision BioSciences, Inc

    Durham, NC
    1 day ago
  • 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... 
    Senior
    Flexible hours

    Beam Therapeutics

    Durham, NC
    1 day ago
  • 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... 

    ALOIS Solutions

    Durham, NC
    3 days ago
  • 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... 

    Merck & Co.

    Durham, NC
    3 days ago
  • 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

    LeadStack Inc.

    Durham, NC
    3 days ago
  • BioSpace is seeking a Quality Assurance professional in Durham, NC to ensure compliance with regulations and approve quality documentation. The ideal candidate will have at least two years of QA experience, preferably in the pharmaceutical industry, and excellent... 

    BioSpace

    Durham, NC
    5 hours ago
  • Novo Nordisk A/S in Durham, North Carolina seeks a Quality Assurance professional to ensure compliance with regulations and internal standards. The role involves documentation review, root cause analysis, and participation in audits. Candidates should have at least two... 

    Novo Nordisk A/S

    Durham, NC
    4 days ago
  • 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... 

    KBI BioPharma

    Durham, NC
    4 days ago
  •  ...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... 

    Novo Nordisk A/S

    Durham, NC
    3 days ago
  •  ...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... 

    Merck & Co.

    Durham, NC
    3 days ago
  • 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... 

    Fujifilm Corporation

    Durham, NC
    15 hours ago
  •  ...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

    Durham, NC
    4 days ago
  • 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

    KBI BioPharma

    Durham, NC
    4 days ago
  •  ...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

    Insight Global

    Durham, NC
    1 day ago
  •  ...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... 
    Senior
    Remote work

    Oxfordbiom

    Durham, NC
    2 days ago
  • $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... 

    KBI Biopharma, Inc.

    Durham, NC
    1 day ago
  •  ...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

    KBI Biopharma, Inc.

    Durham, NC
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior QA Specialist - cGMP Compliance & Ops. Be the first to apply!