Quality Assurance Specialist (Compliance)

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  • Undisclosed
  • Permanent
  • Oliver Page
  • 02392 314792
  • Email about this job

Blackfield Associates are partnered with a cell and gene therapy organisation based in the Stevenage area, looking for a Quality Assurance Specialist (Compliance) on a fixed-term contract.

As the Quality Assurance Specialist (Compliance), you will be responsible for supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing (GMP)

Other day-to-day responsibilities include but are not limited to:

* Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, complaints, microbiological out-of-trend and out-of-specification results and other
* Authoring, approval and review of GxP documentation
* Review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and desk-based reviews

The preferred candidate for the role will have extensive experience as the equivalent of a quality specialist in a pharmaceutical or Biotechnology manufacturer. The ideal candidate will also have a good understating of working in GxP environments with a degree in a relevant field.

This is a hybrid opportunity which will enable the successful candidate to WFH on a weekly basis.

If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.

STR Limited is acting as an Employment Agency in relation to this vacancy.



Health Economics & Outcomes Research


Market Access, Pricing & Reimbursement

Medical Affairs

Quality Assurance




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