Analyst 1, QC Microbiology
About The Position
The Analyst, QC Microbiology performs operational work in the QC Microbiology laboratory, including microbial testing of in-process drug substance and drug product, environmental and utility monitoring, and raw-material samples. The role performs testing in accordance with written procedures, generally under minimal supervision, and supports sample collection, testing logistics, laboratory materials and supplies, and laboratory information management. The Analyst conducts microbiology testing and reviews and interprets results, including analysis of bioburden, endotoxin, sterility, and microbial findings. The role participates in validation and qualification activities, including isolator qualification, and supports routine equipment operations and maintenance. It also contributes to document preparation and review, project timelines, audit readiness, training and onboarding, CAPA implementation, and the resolution of deviations and non-conformance events. The position is based at FUJIFILM Biotechnologies’ facility in Holly Springs, North Carolina, and requires flexibility to support a 24/7 manufacturing facility.
Requirements
- Bachelor’s degree in a scientific discipline.
- 0–1 year of experience.
- Basic understanding of GMP, GLP, and GDP requirements.
- Knowledge of basic sciences and microbiology laboratory methods and procedures.
- Excellent attention to detail, communication skills, and basic technical writing and problem-solving skills.
- Ability to 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.
- Ability to learn procedures and practices quickly and use data management systems such as TrackWise or LIMS, or learn their basic use and navigation.
- Familiarity with fundamental statistical tools for analyzing data and trends.
- Flexibility to support a 24/7 manufacturing facility.
- Ability to learn and incorporate lean laboratory and Six Sigma principles into daily work.
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
- Support environmental and utilities monitoring sample collection.
- Provide input on sample collection and logistics protocols to help ensure regulatory compliance.
- Coordinate testing materials and supplies; plan and ensure materials are stocked, partnering with procurement, inventory management, and distribution.
- Perform microbiology testing and generate complex data for in-process, raw-material, and environmental samples, including analysis of bioburden, endotoxin, and microbial findings.
- Perform sterility testing and validation processes; participate in isolator qualification and support effective routine operations and maintenance.
- Ensure the accuracy and security of laboratory information and implement tools and protocols for data management.
- Review laboratory testing results, analyze and interpret findings, identify trends, and make informed recommendations.
- Troubleshoot laboratory assay issues 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, aligning work with organizational goals.
- Assist with document preparation and review, project timelines, and training and onboarding of new staff as needed.
- Perform additional duties as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
