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.
• 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.

Knowledge, Skills, And Abilities

• Excellent attention to detail. Looks for opportunities for continuous improvement.
• Basic technical writing and problem-solving skills.
• Excellent verbal and written communication skills.
• Able to manage and complete tasks according to a structured plan.
• Able to complete tasks both independently and with occasional guidance from Supervision.
• Ability to support audit readiness for the laboratory.
• Self-driven, dedicated, and systematic and can plan your day in a structured way.
• Flexible, has a positive attitude, positive energy and open for changes and interested in developing yourself.
• Understanding of GMP, GLP, GDP requirements.
• Knowledgeable in basic sciences and Microbiology laboratory methods and procedures.
• Ability to work cross-functionally with a diverse team.
• Self-motivated and collaborate with junior team members.
• Ability to quickly learn and understand the knowledge of procedures and practices in assigned area.
• Familiarity with fundamental statistical tools to analyze data in relation to trends results.
• Basic understanding and familiarity with data management systems such as Trackwise or LIMS or capability to learn basic use and navigation within the systems.
• Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor's degree in scientific discipline with 0-1 years of experience.
• Basic understanding of GMP, GLP, GDP requirements.

Preferred Qualifications

• Bachelor's 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).