Sr Analyst 1, QC Microbiology

Fujifilm•Holly Springs, NC

19h

About The Position

The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology 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. 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! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Description About This Role 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 Leads sample collection and manages sample logistics for testing Supports testing for all qualification and study directed testing Supports investigation of routine OOS assays and events Conducts qualification and validation protocols Leads sterility testing Reviews intermediate lab testing results Troubleshoots complex assays Writes and assists with document preparation and review Manages project timelines Assists management with 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)

Nice To Haves

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

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
Leads sample collection and manages sample logistics for testing
Supports testing for all qualification and study directed testing
Supports investigation of routine OOS assays and events
Conducts qualification and validation protocols
Leads sterility testing
Reviews intermediate lab testing results
Troubleshoots complex assays
Writes and assists with document preparation and review
Manages project timelines
Assists management with 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