Analyst 1, QC Microbiology

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
• Coincides 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

Minimum Requirements

• Bachelor’s degree in scientific discipline with 0-1 years of experience
• Preferred Requirements: 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)