Analyst 1, QC Microbiology

Fujifilm • Holly Springs, NC

5d • Onsite

About The Position

The Analyst, QC Microbiology is responsible for key operational aspects of the QC Microbiology laboratory and performs microbial testing of in-process drug substance, drug product, environmental and utility monitoring, and raw material samples under minimal supervision. The role carries out testing according to written procedures and contributes to document preparation and review, project timeline management, qualification and validation protocols, and training and onboarding of new staff as needed.

The position supports environmental and utilities monitoring sample collection, coordinates testing materials and supplies, and performs advanced microbiology testing, including analysis of bioburden, endotoxin, and microbial findings. It also performs sterility testing and validation, participates in isolator qualification, supports routine operations and maintenance, reviews and interprets laboratory results, and identifies trends. Under management direction, the Analyst troubleshoots assay issues, supports CAPAs and quality-system resolutions for deviations and non-conformances, maintains laboratory instruments and resources, and participates in projects from concept through execution. The role is based at FUJIFILM Biotechnologies’ biopharmaceutical manufacturing facility in Holly Springs, North Carolina, and must be flexible to support a 24/7 manufacturing facility.

Requirements

• Bachelor’s degree in a scientific discipline.
• Basic understanding of GMP, GLP, and GDP requirements.
• Excellent attention to detail, communication, basic technical writing, and problem-solving skills.
• Ability to manage and complete tasks according to a structured plan, independently and with occasional supervisory guidance.
• Ability to support laboratory audit readiness and work cross-functionally with a diverse team.
• Knowledge of basic sciences and microbiology laboratory methods and procedures.
• Familiarity with fundamental statistical tools for analyzing data and trends.
• Basic familiarity with data-management systems such as TrackWise or LIMS, or ability to learn their use and navigation.
• Ability to learn and incorporate lean laboratory and Six Sigma principles into daily work.
• Flexibility to support a 24/7 manufacturing facility.
• Ability to meet the listed physical demands, including standing and sitting for periods up to 60 minutes, using repetitive hand and wrist motions, handling objects up to 10 pounds, reaching, bending, pushing, pulling, twisting, ascending or descending ladders or similar structures, discerning audible cues, and performing tasks with corrected 20/20 vision including color distinction.
• Minimum qualification: 0–1 year of experience.

Nice To Haves

• Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or Biology.
• Two or more years of intermediate experience in a GMP QC Microbiology laboratory.
• Knowledge of compendial bioburden, endotoxin, and sterility test methods.
• Ability to troubleshoot and maintain laboratory equipment and instrumentation.
• Experience with microbial identification systems such as MALDI or MicroSeq.
• Self-motivation and ability to collaborate with junior team members.
• Interest in continuous improvement, flexibility, positive energy, and professional development.

Responsibilities

• Support environmental and utilities monitoring sample collection.
• Provide input on sample-collection and logistics protocols to ensure compliance with regulatory standards.
• Coordinate testing materials and supplies, plan stock levels, and partner with procurement, inventory management, and distribution to support laboratory operations.
• Perform advanced microbiology testing and analyze bioburden, endotoxin, and microbial findings for in-process samples, raw materials, and environmental samples.
• Perform sterility testing and validation processes, participate in isolator qualification, and support effective routine operations and maintenance.
• Ensure accuracy and security of laboratory information and implement data-management tools and protocols.
• Review laboratory testing results, analyze and interpret findings, identify trends, and make informed recommendations.
• Troubleshoot laboratory assays under management direction, identify causes of assay failures, and develop solutions to improve test reliability.
• Maintain analytical instruments and laboratory resources; coordinate purchases and receipt of essential supplies.
• Support implementation and monitoring of CAPAs.
• Partner with management to initiate and coordinate resolution of deviations and non-conformance events within quality systems.
• Participate in project development from concept through execution, ensuring alignment with organizational goals.
• Assist with document preparation and review, project timeline management, qualification and validation protocols, and training and onboarding of new staff as needed.
• Perform additional duties as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level