Interim QC Specialist

Interim QC Specialist

Final date to receive applications: 4 July 2026

Department: S-MIC Quality

Employment Type: Fixed Term Contract

Location: Stevenage (SMIC)

The Quality Control Specialist will support the activities of CGT Catapult’s GMP Quality Control Laboratories and associated infrastructure and will help ensure that the CGT Catapult Manufacturing Innovation Centres (MICs) in Stevenage and Braintree meet and operate to the standards and expectations of its key stakeholders, regulatory authorities, and potential Collaborators.

• QC Service Support – e.g. Environmental monitoring, microbiology, testing of raw material, in-process material tests, final product testing etc
• Support the tactical execution of laboratory analysis and result reporting to ensure the QC service provision is maintained in line with the requirements of each Collaborator
• Lead technical transfer, validation and routine execution of analytical techniques used for the manufacture, testing, and release of cell and gene therapy products, including flow cytometry, qPCR, ddPCR, ELISA
• As required work with the wider QC team, QA, suppliers and service providers to assist in the development and maintenance of GMP compliant QC Laboratory services and systems
• Prepare, review and report process trending charts for QC activities
• Undertake non-guaranteed overtime as per the Company policy in response to an operational need

• Support the Sample Management function to ensure the QC group provides a timely, effective and efficient service for the collection (from manufacturing modules and other classified areas), transportation, storage and lifecycle management of Collaborator and CGT Catapult derived microbiology and environmental monitoring samples, and manufacturing process and drug substance/product samples requiring testing
• Support Collaborator raw material sampling activity and ensure it is undertaken to GMP standards and in accordance with Collaborator requirements
• Support the continued use and configuration, as required, of the electronic laboratory information management system (LIMS) in accordance with the requirements of GMP
• Leadership and line management supporting a growing group of QC Technicians
• Manage QC scheduling and resource allocation ensuring efficient operation

• Conduct test verifications and analytical method qualifications as required
• Provide support for aseptic process qualifications, e.g. aseptic gowning, good aseptic practices and media fills etc
• Conduct Out of Specification and other laboratory investigations
• Provide training and guidance to the QC team and oversee routine activities to ensure the services are delivered in compliance with GMP standards and other QMS elements

• Provide support to ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards
• Provide support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity)
• Generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc. in compliance with applicable regulatory requirements for the service
• Provide support to ensure the CGT Catapult QC team and associated service providers complete all documentation and records accurately, contemporaneously, and to a consistent GMP standard
• Provide support to ensure the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity
• Lead Change Controls, Out of Trend, Out of Specification and Deviation management events associated with QC services and assist in the implementation, reporting and management of such events to an appropriate and compliant conclusion

• Proven experience working in microbiology or in an aseptic (bio) pharmaceutical manufacturing environment, operating according to GMP, at similar responsibility level
• Demonstrable experience of writing, executing and reviewing GMP documents and processes,…