These are permanent positions, paying up to £28,500 plus excellent benefits. You will be home-based for the time being, with the longer-term intention to be based on site in Stevenage.
We are looking for energetic, open-minded and versatile individuals to join a pioneering company at the forefront of cell and gene therapy. Regulated to strict GMP guidelines, the company has promoted two people from QA Associate to QA Specialist roles and now needs to backfill these QA Associate positions. This will be a perfect opportunity for you to use your range of QA skills and be part of something genuinely exciting. The company has recently expanded from 6 to 12 clean room suites.
The Role:
You will support the QA team in the operation and maintenance of the Manufacturing Centre Quality Management System. This will include managing the issuing, storage, archiving and access of a paper documentation system, generating system performance metrics and acting as “doc admin” in the electronic Quality Management System. You will:
- Provide entry-level QA support in the review and approval of procedures and minor quality records
- Issue controlled GMP documents to the rest of the Manufacturing Centre team
- Perform the role of “doc admin” and “training coordinator” in the MasterControl eQMS
- Issue, review and reconcile controlled documents internally and externally, and maintain satellite files
- Maintain training files and QMS trackers
- Support with Collaborator and external regulatory inspection preparation
- Perform facility walkarounds, assessing for compliance with established procedures
- Review quality documentation including QC laboratory data, minor non-conformances and procedure updates
The Company:
This organisation is at the forefront of cell and gene therapy in the UK and elsewhere. They have a strong reputation for career development opportunities, a busy and varied working environment and genuine collaboration between internal and external parties. Full details of the company, benefits package and overall opportunity will be provided on application.
Skills and Experience Required:
- Good qualification (ideally BSc / MSc or similar) in a Scientific discipline
- Experience of Quality Assurance gained within a commercial setting, ideally in a Biologics, Biotech, Cell Therapy / ATMP or Biopharmaceutical organisation, regulated to GMP standards
- Strong understanding of the use of a Quality Management System – ideally an electronic one such as Trackwise
- Excellent communication skills and ability to work with people at all levels
- Great attention to detail and ability to maintain and manage a range of documentation
- Pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. These are two permanent roles in Stevenage, Hertfordshire, paying up to £28,500.