FUJIFILM Holdings America Corporation · 2 weeks ago
Sr Analyst 1, QC Microbiology
US-NC-Holly Springs
Full-time
Onsite
Mid, Senior Level
2+ years expFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory, performing microbial testing, and training team members on various laboratory procedures.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
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
Qualification
Required
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)
Preferred
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
Company
FUJIFILM Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase