The Analyst 1, 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 1, 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.
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).
