Summary: A Quality Control (QC) Supervisor for dietary supplements oversees the daily inspection and testing of products and materials to ensure they meet stringent industry regulations and company standards. This includes enforcing the FDA's Current Good Manufacturing Practices (cGMP) for dietary supplements (21 CFR Part 111) and managing the team of QC technicians who perform the test.
Duties and Responsibilities:
- Supervise QC team: Lead, train, and manage QC technicians and inspectors on day-to-day tasks. Conduct performance reviews, provide feedback, and coordinate work schedules.
- Manage inspection and testing: Oversee the inspection of incoming raw materials, in-process goods, and finished products. This involves physical, chemical, and organoleptic (taste, odor, color) testing.
- Enforce cGMP compliance: Ensure all QC activities, documentation, and processes adhere to the strict requirements of 21 CFR Part 111.
- Control non-conformance: Direct the investigation of non-conforming products and deviations from specifications. Lead root cause analysis and implement corrective and preventive actions (CAPA).
- Handle product disposition: Manage the "hold and release" process for raw materials and finished products within the company's system. Authorize the acceptance, rejection, or rework of materials based on test results.
- Maintain documentation: Ensure all quality tests, inspections, and activities are thoroughly documented. Review and approve Master Manufacturing Records (MMRs) and other relevant paperwork.
- Support audits and inspections: Assist with internal and external audits, including those from the FDA or third-party certifiers. Act as a point of contact during inspections.
- Oversee lab operations: For supervisors in lab settings, manage the use, maintenance, and calibration of analytical instruments like HPLCs. Conduct and document stability testing on products.
- Lead continuous improvement: Analyze quality metrics and trends to identify opportunities to improve processes and reduce defects
Work Experience/Qualifications:
· Minimum of 3 years’ relevant work experience in quality control laboratories or related field within the food, dietary supplement, or pharmaceutical industry, including at least 1 year supervisory or leadership experience.
· Knowledge of QC methodologies, laboratory testing techniques, and the use of analytical instruments. Experience with quality management systems (QMS) and enterprise resource planning (ERP) software is often preferred
· Excellent leadership, communication, and problem-solving skills to effectively manage a team and collaborate with other departments.
Education Requirements:
· BA Degree or equivalent in relevant scientific fields (chemistry, Food Science, Microbiology...ect) is preferred.
· PCQI and or HCAAP certification preferred.
Work Environment:
· The work environment characteristics described here represent those an employee encounters while performing this job's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes, or airborne particles and risk of electrical shock.
· The noise level in the work environment is usually moderate.
· While in the plant, the employee must utilize the required personal protective equipment.
Physical Demands:
· The physical demands described here represent those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Physical demands require sitting and walking for extended periods of time, bending, reaching, carrying. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.