Quality Assurance Specialist
2 days ago
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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