Analyst, QC Microbiology jobs in United States
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FUJIFILM Holdings America Corporation · 21 hours ago

Analyst, QC Microbiology

FUJIFILM Holdings America Corporation is focused on building the future of bioproduction in Holly Springs, North Carolina. They are seeking a QC Analyst responsible for key operational aspects of the QC Microbiology laboratory, performing microbial testing and managing associated activities in accordance with written procedures.

Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
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H1B Sponsor Likelynote

Responsibilities

Collects samples for Environmental monitoring (EM) and Utilities monitoring (UM). Responsible for all sample collection and logistics as needed
Coordinates testing materials and supplies needed for testing
Performs Basic Microbiology laboratory testing following standard procedures for all samples, including but not limited to all in-process samples, raw materials, EM and utilities samples for Bioburden, Endotoxin, plate reading, and microbial identification
Performs sterility testing, isolator qualification and routine operations and maintenance
Sample and data entry into LIMS system
Reviews general lab testing results
Troubleshoots routine assays
General laboratory support and laboratory maintenance in a cGMP laboratory including maintaining laboratory supplies needed for operations, maintenance of analytical instruments, purchasing and receiving of laboratory supplies (media, kits, etc.)
Ensures CAPAs are being followed in the laboratory areas
Notifies management and assists with the initiation of events (such as deviations) in the quality systems
Assists with projects as assigned
Works 12-hour shift on 2-2-3 cadence, 0600-1800
Performs other duties as assigned

Qualification

MicrobiologyGMPGLPLIMSMicrobial ID systemsFDA regulationsBasic laboratory skillsTroubleshootingDocument preparationProject management

Required

BA/BS in scientific discipline
0-2 years of basic GLP laboratory experience
Understanding of GMP, GLP, GDP requirements
Knowledgeable in basic sciences and Microbiology laboratory methods and procedures
Basic LIMS training

Preferred

BS within Microbiology, Chemistry, Biochemistry, Biology
2+ years of Intermediate experience in a GMP QC Microbiology Laboratory, knowledge of all compendial test methods (Bioburden, Endotoxin, sterility testing) preferred
Ability to troubleshoot and maintain laboratory equipment and instrumentation
Experience with microbial ID systems (MALDI, MicroSeq)
Intermediate LIMS training
Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)
Trackwise System training
Lean / 6S training

Company

FUJIFILM Holdings America Corporation

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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.

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 Stage
Total Funding
unknown
2006-06-13Acquired

Leadership Team

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Deepak Mahulikar
Chief Technology Officer
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Patrícia Colombo
Chief Compliance Officer
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Company data provided by crunchbase