Senior Microbiologist Specialist
7 days ago
The QC Microbiology Senior Analyst 1 is a key operational leader responsible for overseeing the microbiology laboratory. This position involves performing and training others on microbial testing of in-process drug substance, drug product, EM/UM, and raw materials samples. The incumbent will be responsible for all associated activities with this testing in accordance with written procedures.
Responsibilities:- Advanced lab testing and support for all laboratory assays for all samples
- Lead sample collection and manage sample logistics for testing
- Support testing for all qualification and study directed testing
- Lead sterility testing
- Review intermediate lab testing results
- Act as qualified trainer and SME of at least one test
- Troubleshoot complex assays
- Assist with writing of documents. Review and edit documents
- Support investigation of routine OOS assays and events
- Embrace LEAN lab and six sigma principles and apply them to laboratory processes
- Champion projects and project management as assigned
- Bachelor's degree with 2-5 years of relevant Microbiology experience or Master's degree with 0-3 years of relevant Microbiology experience
- Experience with aseptic production & support
- Advanced understanding of GMP, GLP, GDP requirements
- Advanced knowledge in Microbiology theory
- Advanced knowledge of Microbiology testing and laboratory experience
- LIMS experience
- Experience with document control including reviewing and editing technical documents
- LEAN lab and six sigma six training and/or certification
- Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
- Intermediate LIMS software training
- Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)
- BS with 5+ years of experience within Microbiology, Biochemistry, Biology
- MS with 3+ years of experience within Microbiology, Biochemistry, Biology
- 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage
- Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)
- Advanced experience with microbial ID systems, ability to trouble-shoot complex equipment and instrumentation (MALDI, MicroSeq)
- Advanced LIMS / Trackwise software training
- Experience working within a QC laboratory environment commissioning Pharmaceutical and/or laboratory facilities
$120,000 - $150,000 per annum
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