Quality Control Supervisor

Job Summary:

The Quality Control Supervisor leads daily laboratory operations and personnel to ensure accurate, timely, and compliant testing of raw materials, in-process samples, bulk intermediates, stability samples, and finished products. This role provides technical and operational oversight for analytical testing, investigations, method lifecycle activities, instrument readiness, data integrity, safety, and continuous improvement while partnering cross-functionally to support product quality, commercial operations, and regulatory readiness.

Reporting to: Manager, Quality Control
Location/Territory: Johnson City, TN (onsite)

Responsibilities:

• Supervise, coach, develop, and schedule QC laboratory personnel; set priorities, review performance, and foster a culture of accountability, scientific excellence, safety, and continuous improvement.
• Direct routine and non-routine testing of raw materials, in-process samples, bulk intermediates, stability samples, components, and finished products in accordance with approved procedures, compendial requirements, and regulatory expectations.
• Ensure analytical data and records are accurate, complete, timely, and compliant with cGMP, GLP, ALCOA+ data integrity principles, and applicable electronic laboratory system requirements.
• Provide technical oversight for HPLC, GC, UV-Vis, FTIR, Karl Fischer, wet chemistry, ICP or equivalent elemental analysis, and other laboratory instrumentation; escalate or coordinate resolution of complex issues.
• Review and approve laboratory data, notebooks, electronic records, calculations, specifications, certificates of analysis, SOPs, test methods, protocols, and reports.
• Manage OOS, OOT, deviation, and nonconformance investigations; ensure scientifically sound root cause analysis, impact assessment, and timely CAPA completion.
• Plan and oversee method development, verification, transfer, qualification, validation, robustness assessment, and lifecycle management in alignment with USP, EP, JP, ICH Q2(R2), and FDA expectations.
• Maintain instrument lifecycle readiness through qualification, calibration, preventive maintenance, troubleshooting, and technology upgrades in partnership with Validation and Engineering.
• Manage internal and contract laboratory workloads, priorities, turnaround times, staffing plans, supplies, and departmental budget inputs to support operational commitments.
• Maintain laboratory safety, cleanliness, documentation, and inspection readiness; enforce EHS, PPE, hazardous-material, and near-miss reporting requirements.
• Represent QC during internal and external audits and serve as a technical escalation point for analytical methods, laboratory systems, and data integrity practices.
• Partner with Quality Assurance, Manufacturing, R&D, QA Validation and Supply Chain to resolve product-quality issues and support method readiness, technology transfers, and commercial operations.
• Lead continuous improvement initiatives, including 5S, Lean or kaizen activities, workflow optimization, error prevention, analytical throughput improvements, and harmonization of laboratory practices.
• Establish and monitor training and qualification programs for laboratory personnel, including chromatography, instrumentation, investigations, documentation, and data integrity.
• Perform additional duties, projects, and training assignments as directed by senior Quality leadership.

Required Qualifications and Skills

• Bachelor’s degree in Chemistry or a related scientific discipline.
• Typically 7 or more years of experience in a cGMP/GLP laboratory environment, including at least 1 years of direct supervisory or team-lead experience.
• Demonstrated knowledge of cGMP, GLP, FDA 21 CFR Part 211, USP/EP/JP compendial requirements, ICH Q2(R2), and ALCOA+ data integrity principles.
• Strong technical knowledge of chromatography and analytical instrumentation, including HPLC, GC, ICP-MS, UV-Vis, FTIR, Karl Fischer, wet chemistry, and related laboratory systems.
• Experience overseeing analytical investigations, root cause analysis, CAPA, method transfer, validation or verification, instrument qualification, and method lifecycle activities.
• Ability to critically review complex analytical data, identify aberrations, make sound risk-based decisions, and communicate technical conclusions clearly.
• Proven ability to lead, coach, train, and develop laboratory personnel while managing priorities, resources, and multiple projects.
• Strong scientific writing, document-review, organizational, and time-management skills.
• Excellent written and verbal communication skills, including cross-functional collaboration and representation of QC during audits and technical discussions.
• Proficiency with Microsoft Office and familiarity with LIMS, chromatography data systems, EQMS and other electronic QC workflows.

Preferred Qualifications

• Experience in pharmaceutical, OTC, cosmetic, or medical-device manufacturing.
• Experience leading laboratory modernization, 5S, or other continuous improvement initiatives.

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