Quality Supervisor (Supplement & Food Safety)

SUMMARY :

The Quality Supervisor oversees and ensures compliance with FDA 21 CFR Part 111 regulations related to the manufacturing, packaging, labeling, and holding of dietary supplements. This role manages day-to-day quality operations, including batch record review, deviation investigations, internal audits, and supervision of QA / QC staff.

DUTIES AND RESPONSIBILITIES :

• Supervise the implementation and enforcement of all applicable cGMP requirements per 21 CFR Part 111 and 21 CFR 507.
• Review and approve Master Manufacturing Records (MMRs) and Mater Packaging Records (MPRs).
• In charge of Incoming Material and Finished product disposition in ERP system.
• In charge of the Food Safety Program.
• Oversee incoming material inspection, in-process checks, and final product release.
• Investigate and document non-conformances, deviations, and out-of-specification (OOS) results.
• Support and manage internal audits, third-party audits, and FDA inspections.
• Ensure proper documentation practices and control of SOPs, forms, and logs.
• Coordinate employee GMP training and maintain training records.
• Support Quality Control in environmental monitoring, stability testing, and lab operations.
• Execute, monitor and trend CAPA, change control, complaints, and quality metrics.
• Lead root cause investigations and help drive continuous improvement initiatives.
• Assist in the preparation and review of Annual Product Reviews (APR) and quality reports.
• Manage the Retain Annual Evaluation, Environmental Monitoring and Pest Control Program
• Performs other related duties as assigned by management.

SUPERVISORY RESPONSIBILITIES :

QUALIFICATIONS :

PCQI preferred

Spreadsheet Software (Excel);

Flexible hours based on business demands.