Quality Supervisor (Animal Food Facility)

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:

• Supervises 3-6 employees within one department.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS:

• Bachelors degree in Life Sciences, Chemistry, Pharmaceutical Sciences, or related field.
• 35 years of experience in Quality Assurance or Quality Control in a 21 CFR 111-regulated facility.
• Strong working knowledge of dietary supplement GMPs, especially Subparts E, F, G, H.
• Experience with batch record review, CAPA systems, deviation investigations, and audits.
• Experience with EPRs system, preferred.
• Familiarity with FDA, NSF, or third-party inspections.

• Certificates, licenses and registrations required:
  • PCQI preferred

• Computer skills required:
  • Spreadsheet Software (Excel);
  • Word Processing Software (Word);
  • Electronic Mail Software (Outlook);
  • Presentation software (PowerPoint);
• Other skills required:
• Able to work in a fast-paced environment.
  • Flexible hours based on business demands.
  • Supervisory experience with QA/QC technicians or specialists.
  • Experience with electronic quality management systems (eQMS).
  • Strong written and verbal communication skills.
  • Ability to manage multiple priorities in a fast-paced GMP environment.