Job Description
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Quality Assurance Associate – Shift-Based Role (Stevenage)
Role Summary
Based in Stevenage, this position sits within the Quality Assurance (QA) team and plays a key role in supporting the delivery of autologous CAR T-cell therapies for both commercial use and clinical trials. Operating from a central GMP facility, the role ensures the highest standards of Good Manufacturing Practice (GMP) across products destined for the UK, EU, and US.
Shift Pattern
This is a shift-based role, offering two consistent weekly patterns:
* Sunday to Wednesday, 8:00 AM – 5:45 PM
* Wednesday to Saturday, 8:00 AM – 5:45 PM
Successful candidates will be assigned to one of these shifts.
Recruitment Process
We will be recruiting for this role through an Assessment Centre in May, where candidates will engage in interactive evaluations to demonstrate their technical and behavioural fit for the position.
Key Responsibilities
* Maintain GMP compliance in a multi-product cell and gene therapy facility
* Support batch release activities by reviewing batch manufacturing and quality control records
* Manage production and QC documentation with full traceability and audit readiness
* Prepare and verify patient- and batch-specific labels in compliance with templates and regulatory standards
* Identify and escalate compliance risks and contribute to improvement actions
* Support inspection readiness, document archiving, and generation of departmental metrics
* Participate in quality investigations and root cause analysis
* Collaborate with internal departments on quality matters and contribute to continuous improvement of the Pharmaceutical Quality System (PQS)
* Work in accordance with local Health and Safety policies and SOPs
Skills & Competencies
* Strong attention to detail and accurate data entry
* Good communication, prioritisation, and decision-making skills
* Flexibility, reliability, and a proactive team-oriented mindset
Qualifications & Experience
* Preferred: Experience in GMP environments and cleanroom work
* Preferred: Higher education (e.g., BSc in pharmaceutical sciences, immunology, biology, or chemistry)
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