Microbiology Investigations Assistant Manager

Job Purpose:

Microbiology Investigation Assistant Manager manages and ensures compliance with FDA regulations in areas of non-conformance investigations, memorandums, deviations, and corrective and preventive actions (CAPAs) for the Microbiology department. Creates and executes investigation and project work plans and revises, as appropriate, to meet changing needs and requirements. Identifies resources needed and assigns individuals responsibilities. Manages day-to-day operational aspects of the investigation process.

Essential Duties and Responsibilities:

• Manages and provides support for the completion of CAPAs, Quality Events (QEs), excursions, memorandums, and deviations as they pertain to the Microbiology department.
• Bridges the gap between Microbiology and other departments.
• Works closely with R&D and QC management to ensure coordinated investigations and/or projects are assigned and communicated between all of microbiology.
• Reviews reports, training, and data for impacted departments to ensure all training related to investigations are completed.
• Establishes a timeline for each phase of investigations, as well as a completion date for the entire project.
• Ensures investigation documentation is complete and current.
• Microbiology Standard Operating Procedure (SOP) review, revision and creation
• Ensures all Microbiology investigations are completed in a thorough, expeditious manner to meet the needs of the company.
• Works collaboratively with the Quality Investigations Team, if needed, with attention to any repeated occurrences of similar root causes.
• Communicates all Microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the Assistant Director of Microbiology, VP of Operational Excellence, or designee.

Supplemental Functions:

• Performs other duties as assigned.