QA Associate, Cell Therapy GMP

Autolus, Inc.; United Kingdom; Remote; GBP 28,000 - 38,000; Full time

Job summary

Autolus is seeking a QA Associate based in Stevenage to join the Quality Assurance team supporting autologous cell therapies for clinical trials and commercial use. The role emphasizes delivering high-quality service, maintaining GMP standards, and collaborating with cross-functional teams across UK, EU, and US sites from our Stevenage GMP hub.

The ideal candidate will have GMP experience, strong attention to detail, and the ability to manage multiple tasks under regulated conditions.

Qualifications

• Experience with GMP systems and controlled documentation.
• Ability to work in a cleanroom environment.
• BSc in pharmaceutical sciences or related discipline.

Responsibilities

• Maintain GMP in a multi-product facility delivering cell and gene therapies for clinical trial and commercial purposes.
• Interact with various functions to ensure cGMP compliance in batch release activities.
• Review Batch Manufacturing Records and QC records and escalation of quality issues.
• Prepare and check in-process and Drug Product labels, ensuring traceability and regulatory compliance.
• Identify potential compliance risks and recommend improvements.
• Support in generation of departmental metrics and archiving of documentation.

Skills

Communications

Detail oriented

Data entry accuracy

Prioritisation

Decision making

Scheduling

Reliability

Team oriented

Education

BSc in pharmaceutical sciences

Job description

Autolus is seeking a QA Associate based in Stevenage to join the Quality Assurance team supporting autologous cell therapies for clinical trials and commercial use. The role emphasizes delivering high-quality service, maintaining GMP standards, and collaborating with cross-functional teams across UK, EU, and US sites from our Stevenage GMP hub.

The ideal candidate will have GMP experience, strong attention to detail, and the ability to manage multiple tasks under regulated conditions.