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Senior Microbiologist

2 months ago

Holly Springs North Carolina, United States Fujifilm Full time
About This Role

The QC Microbiology Senior Analyst 1 is a key member of our team, responsible for leading the operational aspects of the QC Microbiology laboratory. This role involves performing and training others on microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. The incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures.

Key Responsibilities
  • Perform 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
  • Perform other duties, as assigned
Requirements
  • 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)
Preferred Qualifications
  • 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