Senior Analyst 1, QC Microbiology
About the role
The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. This role performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.
Responsibilities
- Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test
- Supports testing for all qualification and study directed testing
- Supports investigation of routine OOS assays and events
- Conducts qualification and validation protocols
- Reviews intermediate lab testing results
- Troubleshoots complex assays
- Writes and assists with document preparation and review
- Manages project timelines
- Aids in training and on-boarding of new staff as needed
- Embraces LEAN lab and six sigma principles and applies them to laboratory processes
- Champions projects and project management as assigned
- Performs other duties, as assigned
Requirements
- Bachelor’s with 2+ years of relevant Microbiology experience OR Master’s with 0 years of experience
- Experience with aseptic production & support 1-3 years in a GMP environment
- 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 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)
Qualifications
- Bachelor’s with 2+ years of relevant Microbiology experience OR Master’s with 0 years of experience
- Master’s with 1+ years of experience
- 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 troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)
- Advanced LIMS / Trackwise software training
- Experience working within a QC laboratory environment, commissioning Pharmaceutical and/or laboratory facilities
Preferred Qualifications
- Bachelor’s with 2+ years of relevant Microbiology experience OR Master’s with 0 years of experience
- Master’s with 1+ years of experience
- 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 troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)
- Advanced LIMS / Trackwise software training
- Experience working within a QC laboratory environment, commissioning Pharmaceutical and/or laboratory facilities
Pay
Competitive salary commensurate with experience.
Schedule
Full-time, Monday through Friday, 8:00 AM - 4:30 PM.
Benefits
Comprehensive benefits package including medical, dental, vision, retirement savings plan, and paid time off.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!
Job Description
Job Description
Company Overview
Company Overview
Equal Opportunity Employer
EEO Information
ADA Information
ADA Information