Analyst, QC Microbiology

The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.

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!

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

What You'll Do

• 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
  
  

Minimum Requirements

• 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 Requirements

• 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
  
  

Physical And Work Environment Requirements

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to ascend or descend ladders, scaffolding, ramps, etc

Ability to stand for prolonged periods of time up to 60 minutes.

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to sit for prolonged periods of time up to 60 minutes.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

Will work in small and/or enclosed spaces.

Will work in heights greater than 4 feet.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).