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Senior Laboratory Microbiologist
1 month ago
We are seeking a highly skilled Senior Laboratory Microbiologist to join our team at Merck. This is an exciting opportunity for a motivated professional to take on a challenging role in our Quality Control - Microbiological/Sterility Testing Laboratory.
About the RoleThe successful candidate will be responsible for providing technical and practical expertise for Microbiology and Sterility test methods, liaising with other sites, and assisting different functions on site for investigations, troubleshooting, change, and CAPA implementation in relation to aseptic manufacture and monitoring.
Main Responsibilities- Perform and oversee testing of all samples submitted to the micro and sterility department, including EM, water, intermediate, and finished products, in accordance with GMP, dossier, quality guidelines, and relevant pharmacopoeia requirements.
- Train new staff and provide ongoing training on new or improved methods, ensuring training documents are kept up to date.
- Chair Environmental monitoring meetings and author Environmental monitoring trend reports.
- Provide required data for Product Quality Reviews as needed.
- Ensure timely completion of results in SAP and maintain up-to-date specifications for microbiology lab tests.
- Assist lab leads in ensuring successful CAPA completion and verification, including training staff in new/improved test methods.
- Offer support to Production for manufacturing issues relating to QC testing.
- Act as Health and Safety representative for QC:
- Participate in departmental safety meetings.
- Qualify as COSHH, Manual handling, and Risk Assessor.
- Promote safety within laboratory areas by carrying out safety observations, ensuring correct signage, and maintaining COSHH documentation to prevent or reduce unnecessary exposure to hazardous substances.
- Support the team leader in preparing the schedule for the Microbiology/Sterility Lab and laboratory work, including arranging cover for weekends and holidays.
- Assist Procurement and QA with changes related to external suppliers of test materials and other critical consumables used for testing.
- Microbiology/Sterility lab experience.
- GMP Compliance and SAP/LIMS knowledge.
- Experience with excellent understanding of testing within a laboratory environment.
- Laboratory investigations, method, and equipment validation, method transfers.
- Project management.
- Proficient in using Microsoft Office, especially Excel and Word.
- Good Protocol, hypothesis, and Report writing skills.
- Good Time Management in a high flow-through laboratory.
- Flexible approach to changing priorities.
- Degree in Microbiology or related Biological Sciences.
