Quality Assurance Specialist

2 days ago


Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full time

Job Summary:

Blackfield Associates is currently supporting a leading clinical-stage biopharmaceutical company in their search for a Quality Assurance Specialist. As a Quality Assurance Specialist, you will support the delivery of autologous CAR T-cell products for clinical trials across the UK and EU.

Key Responsibilities:

  • Ensure Good Manufacturing Practice (GMP) compliance and manage various quality-related activities.
  • Maintain GMP standards in a multi-product facility delivering cell and gene therapies for clinical trials.
  • Ensure cGMP compliance in batch release activities, including reviewing Batch Manufacturing Records and Quality Control records, and escalating quality issues.
  • Manage 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.
  • Ability to work in a fast-paced environment and prioritize tasks effectively.

Working Hours:

Wednesday to Saturday or Sunday to Wednesday, 8 am to 5 pm.



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