Senior QA Specialist Hertfordshire 12-Month Contract | Competitive Salary
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.
Requirements
- Experience within Pharmaceutical, Biotech, Cell Therapy, Gene Therapy, or ATMP environments.
- Strong knowledge of GMP quality systems and regulatory compliance.
- Experience within 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.
What's on Offer?
- 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.
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Senior QA Specialist I employer: RBW Consulting
Join a dynamic healthcare manufacturing site in Trefriw, North Wales, where you can make a significant impact as a Laboratory Supervisor. We offer a supportive and collaborative work culture that prioritises professional growth, with opportunities to lead a dedicated team and influence quality standards. Enjoy a competitive salary, career development prospects, and the chance to work in a beautiful location while contributing to meaningful advancements in laboratory science and compliance.
