QA Specialist - Stevenage, United Kingdom - Autolus

Autolus

Verified Company

Stevenage, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 multiproduct 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 inprocess and Drug Product labels, ensuring compliance with the authorised template and the batchspecific/patientspecific 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 outoftrend and outofspecification results and other environmental excursions
Review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and deskbased 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)