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QC Microbiology Analyst
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Microbiology Lab Supervisor Career Profile
Microbiology Lab SupervisorThe Microbiology Lab Supervisor ensures compliance across the quality control microbiology function.
- Oversee microbiology laboratory design and qualification to include equipment selection, qualification and maintenance.
- Development and maintenance of the facility environmental monitoring program
- Microbial method validation, material and product assessments and product and raw material testing programs.
- Provide oversight to the laboratory design, equipment requirements and qualification.
- Develop and maintain the Microbiology Laboratory Master Plan and develop and oversee the plant hygiene and environmental monitoring programs.
- Oversee the validation of new equipment and test methods and on-going re-qualification of existing equipment.
- Review validation and qualification protocols and reports as necessary.
- Provide direction and leadership for the Microbiology Laboratory developing staff to improve individual and departmental performance.
- Provide training to members of the department and other departments as necessary.
- Support development of new methods to improve laboratory compliance and efficiency.
- Oversee laboratory investigations to assure timely notification to management of results and resolution of issues.
- Provide input for risk assessments.
- Review and approve product and raw material specifications and test methods.
- Provide data trending in support of annual product and quality system reviews.
- Develop departmental and site metrics to detect potential signals and drive improvements. Participate on teams for new product introductions and post-approval/launch changes.
- Interact with Regulatory Health Authorities during inspections and providing input to responses to Health Authorities.