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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.

Main Responsibilities:

  • 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.

Requirements:

  • 1 to 2 years of experience in a quality assurance role within a pharmaceutical or similar quality management system.
  • BSc in pharmaceutical sciences, immunology, biology, or a related discipline.

Working Hours: Wednesday to Saturday or Sunday to Wednesday, 8 am to 5 pm.