Manager Quality Control Laboratory

Position: MANAGER QUALITY CONTROL LABORATORY

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MANAGER QUALITY CONTROL LABORATORY

Regular Full-Time Executive Largo, FL, US

4 days ago Requisition

PRIMARY

PURPOSE:

The Quality Control Laboratory Manager will lead and manage the Quality Control Laboratory to ensure all analytical testing, material disposition, and laboratory operations are performed accurately, efficiently, and in full compliance with regulatory and company standards. This role is responsible for maintaining the integrity of testing processes, supporting product quality and safety, driving continuous improvement, and developing laboratory personnel while collaborating cross-functionally to support manufacturing and analytical development activities.

MAJOR

DUTIES AND RESPONSIBILITIES:

• Drive a culture of accountability, ownership, and performance excellence throughout the Quality Control Laboratory organization by establishing clear expectations, monitoring performance metrics, reinforcing compliance standards, and ensuring timely execution of commitments and corrective actions.
• Provide leadership and oversight for the daily operations, workflow scheduling, and performance of the Quality Control Laboratory, ensuring efficient execution of all analytical testing activities.
• Supervise, mentor, and develop Quality Control laboratory personnel through training, coaching, performance management, and succession planning initiatives to support organizational growth and technical competency.
• Ensure timely and compliant execution of analytical testing for raw materials, in-process materials, finished products, cleaning validation samples, environmental monitoring samples, and stability samples in accordance with approved specifications and testing procedures.
• Review and disposition raw materials, in-process materials, finished products, and cleaning validation results to support manufacturing operations and product release activities.
• Lead and oversee laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), atypical results, deviations, laboratory events, and corrective and preventive action (CAPA) implementation in accordance with regulatory and internal quality system requirements.
• Ensure laboratory compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), FDA regulations, USP compendial requirements, data integrity standards, and internal Standard Operating Procedures (SOPs).
• Develop, review, approve, and maintain laboratory procedures, test methods, specifications, protocols, reports, and associated quality system documentation.
• Collaborate cross-functionally with Analytical Research & Development (AR&D), Quality Assurance, Manufacturing, and Technical Services to support analytical method development, validation, verification, troubleshooting, method transfer and New Product Launch activities.
• Oversee incoming material inspection and approval processes, including review of Certificates of Analysis (COAs), Incoming Inspection Reports, and verification of compendial compliance requirements.
• Manage laboratory stability programs and retain sample programs, ensuring samples are properly controlled, tested within required timelines, and documented in accordance with regulatory commitments and approved protocols.
• Direct laboratory metrology and equipment lifecycle management activities, ensuring analytical instrumentation is properly qualified, calibrated, maintained, and operating in a validated state.
• Monitor laboratory performance metrics, testing turnaround times (cycle times), investigation trends, and operational efficiencies to support continuous improvement initiatives and overall laboratory effectiveness.
• Lead continuous quality improvement and laboratory transformation initiatives focused on process optimization, workflow standardization, operational efficiency, and implementation of sustainable quality system enhancements.
• Ensure accurate documentation, review, analysis, and interpretation of analytical data in compliance with data integrity requirements and approved…