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Quality Assurance Specialist

2 months ago

Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full time

Quality Assurance Specialist

Blackfield Associates is currently supporting a leading clinical-stage biopharmaceutical company in their search for a Quality Assurance Specialist based in the UK.

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. Your responsibilities will include:

  • 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.
  • Preparing, checking, and issuing in-process and Drug Product labels, ensuring compliance with templates and maintaining product traceability.

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. Knowledge of GMP and GCP principles, strong communication skills, and the ability to build collaborative relationships across departments are essential. Reliability, flexibility, and excellent attention to detail are also crucial for success in this role. The working hours for this role are Wednesday to Saturday or Sunday to Wednesday, 8 am to 5.45 pm.