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Senior QA Specialist
Job in
Luton, Bedfordshire, EX14, England, UK
Listed on 2026-10-17
Listing for:
RBW Consulting
Full Time
position Listed on 2026-10-17
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
Are you an experienced QA professional looking to join a cutting-edge biotechnology environment developing life-changing advanced therapies? We are seeking a Senior QA Specialist to provide quality oversight within a GMP-regulated manufacturing environment, supporting the production and release of innovative cell and gene therapy products.
Key Responsibilities- Provide QA support for GMP manufacturing operations within a sterile production environment.
- Review and approve batch records, deviations, CAPAs, change controls, and GMP documentation.
- Support investigations, quality risk assessments, supplier quality activities, and audit programmes.
- Work closely with Manufacturing, QC, Validation, and Regulatory teams to ensure compliance and product quality.
- Contribute to inspection readiness and continuous improvement initiatives.
- Experience with in Pharmaceutical, Biotech, Cell Therapy, Gene Therapy, or ATMP environments.
- Strong knowledge of GMP quality systems and regulatory compliance.
- Experience with in sterile and/or aseptic manufacturing environments is essential.
- Proven experience managing deviations, CAPAs, change controls, investigations, and batch documentation.
- Strong stakeholder management and communication skills.
- Opportunity to work with pioneering advanced therapy products.
- Exposure to a highly innovative GMP manufacturing environment.
- Collaborative and fast-paced culture.
- Competitive salary and comprehensive benefits package.
- 12-month contract offering the opportunity to make a significant impact within a growing organisation.
Position Requirements
10+ Years
work experience
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