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Stevenage Hertfordshire, United Kingdom Blackfield Associates Full time

Blackfield Associates is currently supporting a leading clinical-stage biopharmaceutical company in their search for a Quality Assurance Specialist based in Stevenage .
As a Quality Assurance Specialist, you will support the delivery of autologous CAR T-cell products for clinical trials across the UK and EU. You will work within the Quality Assurance Operations team, ensuring Good Manufacturing Practice (GMP) compliance and managing various quality-related activities. Maintaining GMP standards in a multi-product facility delivering cell and gene therapies for clinical trials.


~ Ensuring cGMP compliance in batch release activities, including reviewing Batch Manufacturing Records and Quality Control records, and escalating quality issues.


~ Managing record forms in production and QC to maintain batch or test article identity traceability, audit trails, and archiving.


~ The ideal candidate will have 1 to 2 years of experience in a quality assurance role within a pharmaceutical or similar quality management system, with a BSc in pharmaceutical sciences, immunology, biology, or a related discipline. Please note the working hours for this role are Wednesday to Saturday or Sunday to Wednesday, 8 am to 5.