Quality Supervisor

Job description : 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.

3-5 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 :

o PCQI preferred

Computer skills required :

o Spreadsheet Software (Excel);

o Word Processing Software (Word);

o Electronic Mail Software (Outlook);

o Presentation software (PowerPoint);

Other skills required :

o Flexible hours based on business demands.

o Supervisory experience with QA / QC technicians or specialists.

o Experience with electronic quality management systems (eQMS).

o Strong written and verbal communication skills.

o Ability to manage multiple priorities in a fast-paced GMP environment.

Job Type : Full-time

Benefits :

401(k)

401(k) matching

Dental insurance

Employee assistance program

Employee discount

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Referral program

Vision insurance

Work Location : In person