Cobra Biologics, now a Charles River company, is a leading international contract development and manufacturing organization (CDMO) specializing in premium plasmid DNA and viral vector services to support the Advanced Therapy Medicinal Products (ATMP) industry. 

 Each of our GMP approved facilities are tailored to serving clients from early stage, to clinical, to commercial scale. Our team takes pride in manufacturing excellence and supporting drug development for the benefit of patients worldwide. 

 Our mission is to continue to expand and cultivate our CDMO offerings in the cell and gene therapy space, providing supply chain simplification through an end-to-end service for development, testing, and manufacturing. We provide our clients with an integrated solution from basic research and discovery through to GMP production. 

 We are currently looking to recruit a Quality Assurance Officer to work in the Quality department at our Keele facility.

 The main duties will include:

  •  Creation and revision of GMP documentation within Quality Assurance.
  • Administration, issue, coordination and review of GMP manufacturing documentation.
  • Providing ‘in suite’ operational QA oversight of GMP manufacture in Grade D and Grade C Facility.
  • Providing Facility Systems support, including HVAC, Pressures, Temperature, Cleaning Logs, Room Release and Room Inspection.
  • Providing support for the timely follow-up and closure of Deviations, Change Controls and CAPA.
  • Assisting as required with internal, supplier and external audits.
  • Working collaboratively with Operations to actively maintain GMP standards.

 You will be educated to degree level or equivalent in a Science subject, with proven relevant Pharma experience in a Manufacturing or Quality Assurance role. You will have good working knowledge of GMP, ideally in the bio-pharmaceutical sector but this is not essential.

 You will demonstrate effective communication skills (verbal and written) and the ability to interact at all levels of the organisation. You will be a proactive team player, both within the department and across the organisation, who is willing to adopt and implement change.

 This role will be based at Keele, Staffordshire.

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