Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

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.

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
• 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

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.