This is a newly-created role for a Senior QA Associate, to join a team of 3 other Senior Associates and a Document Controller. This is part of the company’s exciting expansion in 2021 and will be followed by additional hiring and more opportunities presenting themselves. We are looking for an adaptable, energetic, collaborative, honest and versatile person to join this pioneering company who are at the forefront of T-cell therapy.
This is a permanent position, paying a very generous salary, annual bonus and healthcare, to discuss on application. You will be based primarily on site in modern premises in Stevenage, though there is flexibility for some home-based work.
Reporting to the QA Manager, your role will include:
- Maintaining quality documentation to facilitate GMP production.
- Performing quality review of manufacturing records.
- Reviewing Change Control records impacting T cell therapy product.
- Releasing documents and labels to the manufacturing production teams.
- Providing investigational support of potential deviations for the manufacture, testing, and shipping events to and from the UK.
- Writing and revising quality SOPs and associated documentation
- Supporting quality vendor approval for suppliers, contractors and service providers.
- Assisting in providing training for GMP and GDP
- Performing deviation review and implementation of CAPAs to improve product quality.
Skills and Experience Required:
- Experience of Quality Assurance gained within a commercial Pharmaceutical setting, ideally in a Biologics, Cell Therapy / ATMP, sterile manufacturing or Biopharmaceutical organisation, regulated to GMP standards
- Life science qualification – ideally a degree minimum in a biological discipline
- Experience of working with an eQMS processes (e.g. Trackwise, Veeva, MasterControl, Q-Pulse)
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role in Stevenage, Hertfordshire