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Microbiology Lab Supervisor Career Profile

Microbiology Lab Supervisor

The Microbiology Lab Supervisor ensures compliance across the quality control microbiology function.

Responsibilities
  • 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.