Supervisor, Quality Control

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Job Description

• Oversee daily operations and testing activities within the QC Microbiology Laboratory
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• Ensure timely and compliant execution of microbiological testing to support manufacturing and product release.
• Perform routine review and approval of test data, laboratory records, and associated documentation.
• Support the generation and review of Certificates of Analysis (CoAs) for product release.

• Lead and sustain the site’s Environmental Monitoring (EM) and Utilities Monitoring (UM) programs
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• Monitor environmental and utility data, identify trends, and communicate findings to management.
• Assemble reports and provide routine updates on environmental monitoring performance and compliance.
• Implement corrective and preventive actions when adverse trends or excursions are identified.
• Support optimization of the aseptic gowning qualification and training program.

• Supervise QC Microbiology staff and laboratory activities.
• Conduct performance evaluations, coaching, and regular employee development discussions.
• Maintain training programs and ensure ongoing qualification of QC Microbiology personnel.
• Foster a culture of quality, compliance, accountability, and continuous improvement.

• Serve as Subject Matter Expert (SME) for EM and UM investigations.
• Lead or support investigations involving:
  • Environmental monitoring excursions
  • Utilities monitoring excursions
  • Out-of-Specification (OOS) results
  • Deviations associated with microbiological procedures
• Identify root causes and implement effective corrective and preventive actions (CAPAs).

• Develop, review, revise, and approve:
  • Standard Operating Procedures (SOPs)
  • Validation and qualification protocols
  • Validation and qualification reports
  • Controlled quality documentation
• Monitor GMP systems to ensure continued compliance with internal procedures and regulatory requirements.
• Review proposed changes to methods, procedures, systems, and regulatory submissions as needed.

• Support internal, customer, and regulatory inspections and audits.
• Ensure laboratory activities remain compliant with cGMP requirements and company quality standards.
• Represent the QC Microbiology function during cross-functional, site, and global meetings.

• Collect and analyze departmental metrics to drive continuous improvement initiatives.
• Provide updates and key performance indicators during daily, weekly, and management meetings.
• Collaborate with Manufacturing, Quality Assurance, Validation, Facilities, and other functional groups to support site objectives.
• Perform additional responsibilities and special projects as assigned.

• Bachelor’s degree in Microbiology, Biology, Biochemistry, Life Sciences, or related scientific discipline…