Microbiology Lab Supervisor

• 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.