Responsibilities
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Summary:
Act as the technical subject matter expert for environmental control in aseptic processing and microbiology testing, ensuring compliance and driving continuous improvement through cross-functional collaboration.Key Responsibilities:
- Lead and execute microbiology testing projects, including method validation, transfer, and sanitization studies.
- Perform and oversee bioburden, sterility testing (including Isolator-based testing), and data trend analysis for environmental monitoring.
- Investigate and document excursions, out-of-specification results, and trends, implementing corrective/preventative actions as needed.
- Author and review technical protocols, reports, and laboratory documentation to ensure compliance.
- Train and support laboratory personnel, coordinate with contract labs, and act as the microbiology SME in audits and cross-functional meetings.
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