Quality Control Supervisor

Laboratory Testing and Analytical Execution

• Perform analytical testing in support of in-process, release, stability, environmental monitoring, and investigational testing programs, as needed.
• Execute analytical methods in accordance with approved procedures, protocols, and GMP requirements.
• Perform data analysis and documentation associated with analytical testing activities.
• Serve as a technical resource during execution of complex or high-priority testing activities.

Laboratory Operations, Scheduling, and Workload Management

• Oversee daily execution, coordination, and operational performance of the QC laboratory.
• Manage the QC testing schedule across in-process, release, stability, and environmental monitoring programs.
• Assign assays and workload to QC staff, ensuring alignment with manufacturing timelines.
• Monitor and report QC metrics including turnaround times, deviations, and laboratory capacity.
• Foster a positive, collaborative, and compliance-focused laboratory culture.

Technical Leadership, Method Lifecycle Activities, and Analytical Support

• Lead troubleshooting of analytical methods and laboratory issues, including equipment, reagents, and assay performance.
• Support development, qualification, transfer, and implementation of QC analytical methods for new and existing programs.
• Support data review of analytical data generated by analysts, as needed.

Quality Systems, Investigations, and Compliance Oversight

• Draft, review, and manage analytical deviations, excursions, OOS/OOT investigations, CAPAs, and change controls within an electronic Quality Management System.
• Lead day-to-day execution of laboratory investigations, deviations, environmental monitoring excursions, and OOS investigations, escalating complex events to the QC Manager as appropriate.
• Ensure compliance with applicable GMP, GDP, CFR, USP, and internal quality requirements.
• Track recurring laboratory issues and support continuous improvement initiatives.

Documentation and Continuous Improvement

• Draft, review, and optimize analytical policies, SOPs, protocols, and technical reports.
• Support implementation of laboratory process improvements and operational efficiency initiatives.
• Identify opportunities to improve laboratory systems, workflows, and analytical support activities.

Personnel Leadership, Training, and Employee Development

• Conduct routine one-on-one meetings, performance coaching, training oversight, and employee development activities for direct reports.
• Train, mentor, and coach QC staff on analytical techniques, documentation expectations, and GMP compliance.
• Support onboarding, training effectiveness monitoring, and competency development activities.
• Promote accountability, teamwork, and professional growth within the QC organization.