Analyst 1, QC Microbiology

Overview The Analyst, QC Microbiology is responsible for the key operational aspects of the QC Microbiology laboratory. This role performs microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples under minimal supervision. The Analyst is responsible for all testing activities performed in accordance with written procedures, and participates in writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and onboarding of new staff, as needed and in addition to regular work duties and assignments. What You’ll Do Supports environmental and utilities monitoring sample collection Provides input to define protocols for sample collection and logistics, ensuring compliance with regulatory standards Coordinates testing materials and supplies Plans and ensures materials are stocked; partners with procurement, inventory management, and distribution to optimize laboratory operations Performs advanced microbiology testing, generating complex test data for in-process samples, raw materials, and environmental samples, and provides analysis for Bioburden, Endotoxin, and microbial findings Performs Sterility testing and validation processes and participates in isolator qualification procedures, ensuring effective routine operations and maintenance Ensures accuracy and security of laboratory information, implementing tools and protocols for data management Conducts comprehensive reviews of laboratory testing results, providing analysis and interpretation of results, identifying trends and making informed recommendations Under the direction of management, troubleshoots issues with laboratory assays, identifies underlying causes of assay failures, and develops strategic solutions to improve test reliability Leads general laboratory support and maintenance initiatives by maintaining analytical instruments and laboratory resources, coordinating purchases and receipt of essential supplies Supports implementation and monitoring of CAPAs Partners with management to initiate and coordinate resolution for deviations and non-conformance events within quality systems Participates in project developments from concept through execution, ensuring alignment with organizational goals Performs additional duties as needed Minimum Requirements Bachelor’s degree in a scientific discipline with 0-1 year of experience Preferred Requirements BS in Microbiology, Chemistry, Biochemistry, or Biology 2+ years of intermediate experience in a GMP QC Microbiology setting 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) 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 (View email address on click.appcast.io). #J-18808-Ljbffr FUJIFILM Holdings America Corporation