QA Specialist

3 weeks ago

Stevenage, United Kingdom Autolus Full time

**Location**:

- Stevenage**Job Summary**:
The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing (GMP).

The role is based from our Cell Manufacturing site in Stevenage although hybrid working is available with 2 to 3 days a week required on site. You will be working Monday to Friday, 9am to 5pm (although some flexibility on hours required). The role is a 12 month fixed term contract and we are looking for people to join us in October or November 2023.

Some of the responsibilities 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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