Job Reference: J5633102
Updated On: 25/03/2020
Status: Now Interviewing
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Role OverviewHRS are currently looking for a Quality Control Lead to join a leading Cell and Gene Therapy company based in the Hertfordshire area. As the Quality Control Lead you will be responsible for managing and supporting a growing team and will be instrumental in maintaining the standards of the new Cell and Gene Therapy QC laboratories.
Key Duties and ResponsibilitiesReporting to the Head of Quality, your duties as the Quality Control Lead will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for growing, training and developing a group of Quality Control (QC) Scientists to uphold GMP standards within the Cell and Gene Therapy manufacturing facility.
2. As the QC Lead you will be the biosafety and microbiology expert. You will support Environmental Monitoring, microbiology and biosafety test validations and method qualifications (bioburden, sterility, endotoxin, PCR and flow cytometry).
3. You will generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Qualification protocols and reports.
4. You will also lead Out of Trend, Out of Specification and Deviation management events associated with Quality Control activities within the biopharmaceutical manufacturing environment.
Role RequirementsTo be successful in your application to this exciting opportunity as the Quality Control Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a Microbiology or Life Sciences related discipline plus industry experience using microbiological techniques (bioburden, endotoxin, environmental monitoring) and bio-analytical techniques (RT-PCR, flow cytometry).
2. Proven industry experience working at a supervisory level in a Quality Control role within a GMP licensed aseptic biopharmaceutical manufacturing environment.
3. A working knowledge and practical experience of writing and reviewing GMP documents.
Key Words: QC, Lead, Manager, Microbiology, Biosafety, Environmental Monitoring, Analytical, Life Sciences, Cell Therapy, Gene Therapy, GMP, cGMP, Documentation, OOS, Deviations, Biopharmaceutical, Pharmaceutical, Endotoxin, Sterility, Bioburden, PCR, Flow Cytometry.
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