Purpose

Senior leader in the QC microbiology laboratory responsible for performing, leading, analyzing, and/or documenting microbiological testing within a GMP environment in support of raw materials, in-process materials, finished products, environmental monitoring, sterility assurance, validation, and other microbiological processes. Uses scientific education and/or experience to generate accurate results in accordance with GMP, procedural requirements, and microbiological principles. Interprets and evaluates microbiological data to determine conformance with product and material specifications, including identification of trends in bioburden, microbial recovery, environmental monitoring results, and sterility-related outcomes. Reviews and verifies data generated by others to ensure compliance with specifications and laboratory expectations. Understands internal business processes to appropriately prioritize assigned work and guide others in the laboratory. Has experience and command of multiple microbiological laboratory techniques to perform them with minimal error. Trains other laboratory personnel on microbiological techniques currently included in their training matrix.

Responsibilities

• Leads and influences analysts in the QC microbiology laboratory with their tasks and activities.
• Understands, implements, and maintains GMP with respect to microbiological laboratory records, procedures, and systems in accordance with procedural requirements.
• Proposes and implements changes to maintain and strengthen procedural requirements and microbiological control strategies.
• Performs, leads, analyzes, and/or documents microbiological test methods as written to support product and material release with minimal error.
• Proposes and implements changes to improve microbiological techniques, controls, and laboratory methodology.
• Independently troubleshoots and resolves microbiological assay, technique, contamination, and instrument issues.
• Interprets microbiological and experimental data for conformance with product and material specifications.
• Understands and identifies laboratory technique and instrument performance in accordance with microbiological and scientific principles.
• Initiates appropriate exception documents in accordance with procedural requirements, including deviations, atypical results, OOS/OOT investigations, and contamination events as applicable.
• Implements and ensures improvement ideas are completed to facilitate team objectives. Proposes and implements scientific protocols to determine root cause of exception events.
• Supports or leads investigations related to environmental monitoring excursions, sterility failures, bioburden excursions, microbial identification trends, and aseptic process-related issues.
• Participates in or supports aseptic simulation validations and other microbiological validation activities as needed.