QA Officer

  • Salary: Competitive
  • REF Number: 00056299
  • Consultant: Chloe Merrill
  • Contact: 01246 457720
  • Date Published: 01.12.2023
  • Sector: Biotechnology
  • Location: Cambridge, East Midlands, East Anglia
  • Discipline: Quality

Chloe Merrill is recruiting for a Quality Assurance Officer on behalf of a growing Cell Therapy CDMO to be based at their site near Cambridge on a permanent basis.

About the Company:

Our client is based in state of the art facilities for multi-product GMP manufacturing. Their facilities include GMP research lab space and process development suites, GMP manufacturing suites, QC lab space and cryogenic storage.

Job Summary:

The QA Officer will be responsible for ensuring the QMS isin a state of compliance with relevant regulatory requirements and quality standards throughout the development, manufacturing, and distribution processes of our advanced therapy medicinal products.

About the role:

  • Writing and reviewing Quality documents, Standard Operating Procedures (SOPs) and policies
  • Supporting the operation of the Quality Management System including document control and review, labelling, issuing validation plans and, performing risk assessments
  • Supportingall departments with writing and assessing change controls, non-conformances, root cause analysis, risk assessments and review of Corrective and Preventive Actions (CAPAs)
  • Participate in the inspection process by Regulatory bodies, such as the MHRA and HTA
  • Carry out and support audits and inspections, including internal audits and client audits

About you:

  • BSc in a life sciences subject or related discipline or, comparable experience
  • Proven experience in cellular and/or gene therapies (Biotechnology /CMO) working in a QA role, preferably in a GMP compliant environment
  • Experience in writing QA documents, especially SOP’s, labels and forms
  • Experience with performing and managing risk assessments
  • Experience of performing internal audits
  • Experience of managing deviations, non-conformances and CAPAs


It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56299 in all correspondence.

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