Quality Control Manager

Position Summary

The Quality Control Manager is responsible for overseeing all Quality Control activities within a high-volume nutraceutical manufacturing environment. This position ensures raw materials, in-process products, finished goods, packaging components, and laboratory testing meet established specifications, cGMP requirements, FDA regulations, SOPs, and company quality standards. The Quality Control Manager will lead the QC team, coordinate laboratory activities, investigate out-of-specification results, support production, and ensure accurate and timely release of materials and finished products .

Key Responsibilities

• Manage and supervise daily activities of the Quality Control department and laboratory personnel.
• Oversee testing and inspection of raw materials, in-process materials, finished products, and packaging components .
• Ensure all QC testing is completed according to approved specifications, SOPs, and cGMP requirements.
• Review laboratory data, test results, Certificates of Analysis (COAs), and QC documentation for accuracy and completeness.
• Approve or reject materials and products based on established specifications and testing results.
• Manage OOS (Out-of-Specification), OOT (Out-of-Trend), deviations, and laboratory investigations .
• Ensure investigations are thoroughly documented and appropriate corrective actions are implemented.
• Work closely with Quality Assurance, Manufacturing, R&D, Warehouse, and Regulatory departments.
• Support implementation and monitoring of CAPA programs .
• Maintain laboratory equipment calibration, preventive maintenance, and qualification schedules.
• Ensure proper use and maintenance of analytical equipment such as HPLC, GC, UV-Vis, FTIR, dissolution equipment, balances, and other laboratory instruments , as applicable.
• Monitor environmental, microbiological, and sanitation testing programs when applicable.
• Develop, revise, and maintain QC SOPs, specifications, testing procedures, and laboratory documentation.
• Ensure laboratory records comply with Good Documentation Practices (GDP) and data-integrity requirements.
• Assist with internal, customer, FDA, and third-party audits.
• Identify quality trends and recommend improvements to laboratory processes and manufacturing controls.
• Train, coach, and evaluate QC Chemists, Analysts, Technicians, and other QC personnel.
• Monitor department workload, testing priorities, staffing requirements, and turnaround times.
• Maintain compliance with company safety procedures, PPE requirements, and contamination-control practices.

Qualifications

• Bachelor’s degree in chemistry, Biology, Biochemistry, Pharmaceutical Sciences, Food Science, or related scientific field preferred.
• Minimum 5+ years of Quality Control laboratory experience in nutraceutical, pharmaceutical, dietary supplement, food, or related regulated manufacturing.
• Previous QC supervisory or management experience strongly preferred.
• Strong understanding of FDA regulations, 21 CFR Part 111, cGMP, SOPs, GDP, CAPA, deviations, and OOS investigations .
• Experience reviewing analytical laboratory data and product specifications.
• Knowledge of analytical testing equipment and laboratory methodology.
• Strong leadership, organizational, analytical, and problem-solving skills.
• Ability to work effectively with Manufacturing, QA, R&D, Regulatory, and senior management.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office and laboratory/quality management systems.

Preferred Experience

• Dietary supplement or nutraceutical manufacturing experience.
• High-volume cGMP manufacturing environment.
• FDA or third-party audit participation.
• Laboratory method validation and verification.
• Stability testing programs.
• Microbiology and environmental monitoring.
• Experience managing multiple QC employees and laboratory priorities.

Key Performance Areas

• Accuracy and timeliness of product testing and release
• Reduction of repeat testing and laboratory errors
• OOS and deviation investigation turnaround
• Audit readiness
• Laboratory compliance
• Employee training and development
• CAPA effectiveness
• Documentation accuracy and data integrity