Analyst 1, QC Microbiology

Fujifilm•Holly Springs, NC

7d•Onsite

About The Position

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, QC Microbiology is responsible for all activities associated with testing in accordance with written procedures. This role participates in 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.

Requirements

Bachelor’s degree in scientific discipline with 0-1 years of experience

Nice To Haves

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)

Responsibilities

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 by generating complex test data for in-process samples, raw materials, and environmental samples, providing analysis for Bioburden, Endotoxin, and microbial findings
Performs Sterility testing and validation processes and participates in isolator qualification procedures and ensures 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 and provides analysis and interpretation of results, identifying trends and making informed recommendations
Under the direction of management, troubleshoots issues with laboratory assays and 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