FUJIFILM Holdings America Corporation · 2 weeks ago
Scientist 1, QC Microbiology
US-NC-Holly Springs
Full-time
Onsite
Mid, Senior Level
3+ years expFUJIFILM Holdings America Corporation is building the future of bioproduction in Holly Springs, North Carolina. The Scientist 1, QC Microbiology supports microbiological functions for raw materials and drug product manufacturing, managing complex tasks and ensuring compliance with quality standards.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
Performs non-routine complex testing, identifies requirements and executes actions as part of change control process. Assists and guides others in the lab with routine testing
Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision
Leads qualification and study directed testing activities
Reviews and evaluates advanced lab testing results
Acts as a qualified trainer and Subject Matter Expert (SME) of multiple tests
Authors, reviews, and edits documents and study protocols • Supports intermediate investigations of OOS assays and events
Ensures compliance with cGMP and participates in audits and inspections
Supports laboratory management and mentors’ others on the team, as needed
Leads LEAN lab and six sigma principles and applies them to laboratory processes
Acts as project leader for projects in the lab and department
Leads audit readiness and participates/supports for the team
Performs other duties, as assigned
Qualification
Required
Bachelor's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years' experience OR
Master's degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years' experience OR
PhD with 1+ years of applicable industry experience
3+ years of experience working in a regulated GMP environment
Expert understanding of GMP, GLP, GDP requirements
Experience and proficient knowledge in Microbiology theory
Experience and proficient knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing
Advanced LIMS experience
Advanced experience with document control including writing and editing technical documents and presentations
Preferred
SME level knowledge in Microbiology theory
SME level knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing
Investigations training (Trackwise or similar)
LEAN/6S certification
Familiarity with global regulatory guidelines and testing implications
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