QA Specialist

1 month ago

Stevenage, United Kingdom Autolus Full time

**Location**:

- Stevenage**Job Summary**:
We are currently looking for a QA Specialist to join our product delivery Quality Assurance team, supporting the delivery of autologous T-cell products in compliance with Good Manufacturing (GMP).

The role will be based from our cell manufacturing site in Stevenage. This role is a site based role and you will be shift based, working either Sunday to Wednesday or Wednesday to Saturday (TBC). Your working hours will be 8am to 5.45pm.

Some of the duties include:

- Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies for Clinical trials
- Interact with various functions to ensure cGMP compliance in batch release related activities. Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues
- Preparation, checking and issue of in-process and Drug Product labels, ensuring compliance with the authorised template and the batch-specific/patient-specific data thus maintaining product traceability and regulatory compliance.
- Review of premises and equipment documentation this includes; protocols, reports and equipment maintenance forms
- Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, complaints, microbiological out-of-trend and out-of-specification results and other environmental excursions
- Review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and desk-based reviews
- Supplier management: Review of supplier questionnaires, approval supplier list (ASL), management of supplier management trackers. Maintain and update eQMS records for suppliers.
- Authoring, approval and review of GxP documentation
- Collation and trending of Quality KPIs
- Report or escalate to Line Manager key progress and issues.
- To perform other duties which are directed by the line manager/QA Team Lead.
- Continuous improvement of the Pharmaceutical Quality System (PQS)

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