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. The role performs microbial testing of in-process drug substance, drug product, EM/UM, and raw-material samples under minimal supervision and carries out testing in accordance with written procedures. The Analyst also contributes to document preparation and review, project timelines, qualification and validation protocols, and training and onboarding of new staff as needed. The position supports environmental and utilities monitoring, performs advanced microbiology testing and analysis, conducts sterility testing and validation, and participates in isolator qualification and routine operations. It reviews and interprets testing results, supports investigations and CAPAs, maintains laboratory instruments and resources, and contributes to projects and continuous improvement. The role is based at FUJIFILM Biotechnologies’ Holly Springs, North Carolina facility, which supports a 24/7 manufacturing operation.

Requirements

Bachelor’s degree in a scientific discipline and 0–1 year of experience.
Basic understanding of GMP, GLP, and GDP requirements.
Excellent attention to detail and basic technical writing and problem-solving skills.
Excellent verbal and written communication skills.
Ability to manage and complete tasks according to a structured plan, independently and with occasional supervisory guidance.
Ability to support laboratory audit readiness.
Knowledge of basic sciences and microbiology laboratory methods and procedures.
Ability to work cross-functionally with a diverse team, collaborate with junior team members, and learn procedures and practices quickly.
Familiarity with fundamental statistical tools for analyzing data and trends.
Basic understanding of data-management systems such as Trackwise or LIMS, or ability to learn their basic use and navigation.
Flexibility to support a 24/7 manufacturing facility.
Ability to operate in an environment with a motor vehicle or Powered Industrial Truck.
Ability to discern audible cues and perform tasks with 20/20 corrected vision, including distinguishing colors.
Ability to ascend or descend ladders, scaffolding, and ramps.
Ability to stand and sit for prolonged periods, up to 60 minutes.
Ability to perform repetitive motions involving wrists, hands, or fingers.
Ability to move objects weighing up to 10 pounds; bend, push or pull; reach for materials 18 to 60 inches in height; and use twisting motions.

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 test methods, including Bioburden, Endotoxin, and sterility testing.
Ability to troubleshoot and maintain laboratory equipment and instrumentation.
Experience with microbial identification systems such as MALDI or MicroSeq.

Responsibilities

Perform microbial testing of in-process drug substance, drug product, EM/UM, and raw-material samples in accordance with written procedures.
Support environmental and utilities monitoring sample collection and provide input on sample-collection protocols and logistics.
Coordinate testing materials and supplies, ensure materials are stocked, and partner with procurement, inventory management, and distribution.
Perform advanced microbiology testing and analyze Bioburden, Endotoxin, and microbial findings for in-process, raw-material, and environmental samples.
Perform sterility testing and validation processes and participate in isolator qualification, routine operations, and maintenance.
Ensure the accuracy and security of laboratory information and implement data-management tools and protocols.
Review laboratory test results, 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 and coordinate purchases and receipt of 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 projects from concept through execution, ensuring alignment with organizational goals.
Assist with document preparation and review, project timelines, qualification and validation protocols, and training and onboarding of new staff as needed.
Perform additional duties as needed.