QC Lab Supervisor

Position Details

The Finished Product Quality Control Laboratory Supervisor leads daily QC operations in an FDA-regulated manufacturing environment. This role oversees staff, resources, analytical testing, data integrity, inspection readiness, continuous improvement, and regulatory support to ensure accurate, timely results and compliance with cGMP, FDA, and Phibro quality systems.

Job Responsibilities

• Plan and direct laboratory testing, studies, and projects supporting production, product release, stability, validation, and regulatory submissions.
• Set priorities, assign work, manage resources and timelines, and ensure effective use of personnel and equipment.
• Review data, reports, protocols, and product-disposition recommendations for scientific accuracy, completeness, and compliance.
• Provide basic HR support. Lead, coach, train, and evaluate laboratory personnel; maintain staff competency, development, and safe working practices.
• Provide technical oversight for laboratory methods and equipment, including HPLC, GC, UV/VIS, FTIR, balances, pH meters, titrations, sieves, and ovens.
• Ensure testing and documentation comply with FDA cGMP, GMP/GLP/GDP principles, SOPs, specifications, and data-integrity requirements.
• Maintain inspection readiness and oversee deviations, OOS or atypical results, nonconformances, CAPAs, and effectiveness checks.
• Oversee method validation, verification, transfer, lifecycle management, and continuous improvement.
• Ensure instruments are suitable, qualified, calibrated, maintained, and used in accordance with approved procedures.
• Evaluate SOPs, protocols, studies, and regulatory documentation with appropriate functions to support compliant, efficient operations and required changes.
• Support preparation and review of regulatory documents, including Annual Product Reviews, VMFs and NADAs.
• Communicate laboratory status, risks, findings, and recommendations clearly to management, staff, customers, vendors, and external partners.
• Prepare audit-ready technical reports and presentations, present data-based recommendations, and participate in internal and external audits.
• Monitor scientific, industry, and regulatory developments and implement appropriate changes.
• Partner with Manufacturing, Quality Assurance, Engineering, Product Development, Regulatory, Supply Chain, and external laboratories on product release, investigations, troubleshooting, method transfers, specifications, and projects.
• Enforce laboratory safety, chemical-handling, waste-management, and applicable aseptic practices; ensure hazards and incidents are promptly addressed.
• Support budgeting, workforce planning, performance reviews, personnel recommendations, and department goals.
• Anticipate operational issues, recommend solutions, and assume delegated manager responsibilities when needed.

Education & Experience

Bachelor’s degree or higher in Chemistry, Biochemistry, Microbiology, Biotechnology, or a related field with 7–10 years of relevant scientific experience; alternatively, 12 or more years of related laboratory experience. The above should include 4 or more years in a regulated environment and preferably 2 or more years in a supervisory role.

Technical Skills Requirements

• Demonstrated ability to lead analysts, manage complex priorities, develop staff, and deliver results consistent with Phibro values.
• Proficiency with HPLC, GC, UV/VIS, FTIR, and common laboratory equipment and techniques.
• Working knowledge of FDA regulations, cGMP, ICH, USP, and GMP/GLP/GDP documentation and data-integrity practices.
• Proficiency with Microsoft Office, Minitab, Empower CDS, JDE, LIMS, and electronic laboratory records.
• Strong attention to detail, organization, communication, problem-solving, and continuous-improvement skills.