Quality Specialist

Company Summary

The Quality Compliance Specialist is responsible for supporting and maintaining the company’s Quality Management System to ensure compliance with federal, state, and third‑party regulatory requirements. This role oversees product certification programs (e.g., Kosher, Halal, Organic, Non‑GMO, Gluten‑Free, Vegan), ensures regulatory compliance with FDA standards including 21 CFR Part 117, and partners cross‑functionally with R&D, Procurement, and Quality teams to maintain accurate documentation and certification status.

The specialist exercises independent judgment to support audit readiness, regulatory adherence, and continuous quality improvement initiatives.

NO EXTERNAL RECRUITERS PLEASE

• No Sponsorship/Transfer Available

• Applied knowledge of US FDA regulatory matters Parts 111, 117, 210/211 of the FDA Code of Federal Regulations (e.g., FSMA, FSVP, cGMP), and regulatory matters in other jurisdictions (e.g., Health Canada).
• Single Point of Contact (SPOC) for certification programs; you will develop, implement, and manage the administration of all 3rd‑Party product certification programs i.e.:
  Kosher, Halal, Non‑GMO, Organic, Gluten‑Free, Vegan, etc.
• Works cross‑functionally with R&D, Technical Services, Planning and QC teams to review formulas and manufacturing processes that need to be compliant with Federal and policy regulations (FDA), other 3rd‑party regulatory entities.
• Coordinates with production and planning schedules to ensure batch records are issued to the floor prior to production need.
• Facilitates Material Review Board (MRB) and Quality Management Reviews meetings.
• Leads mock recalls and trace exercises.
• Assists in the management of Change Controls, Deviations, Non‑conformances, and CAPAs for Quality.
• Participates in inspections and audits from State, Federal, 3rd‑party certifiers, and customer inspections.
• Supports audit readiness for Organic, Kosher, Halal and others as required to ensure compliance.
• Conducts internal audits to ensure compliance within the organization by following up with implemented programs (GMPs, Good Hygiene Practices, HACCP, Allergen Control, Cleaning and Sanitation, Pest Control, Equipment Calibration, Organic Certification, etc.) to ensure compliance by all employees and other personnel in the manufacturing facility.
• Works with global purchasing department to establish quality requirements for external suppliers.
• Completes requests from contract customers for pre‑audit questionnaire completion, GMP certifications, licenses and registrations, etc.
• Responsible for the company licenses and permits (Federal, State, and City registrations).
• Works periodically on the manufacturing floor to support in‑process inspection, AQL and sampling.

• Bachelor’s degree in food science or equivalent is required.
• Minimum of 3 years’ experience in food and dietary supplement, labeling, regulatory, manufacturing, retail and/or similar experience.
• Critical thinking abilities with self‑motivation to dive into details as needed.
• Must have working knowledge of industry regulatory compliance standards FDA 21 CFR Parts 111, 117 (Dietary Supplements) or 210 and 211 (Drug Manufacturing).
• PCQI Certified.
• Prefer expertise in 3rd‑party compliance standards (Organic, Kosher, Halal, Non‑GMO).
• Knowledge of local, state, and federal regulations applicable to the plant’s business is desired.
• Must be proficient in MS Office (Word, Excel, PowerPoint, Visio, MS Teams) and Adobe Acrobat.
• Must be organized, meet deadlines, and prioritize tasks efficiently and create a workflow for the process.
• Excellent communication skills:
  Must read, write, and understand English to communicate at various organizational levels.
• Internal auditing and an understanding of HACCP are desirable.
• Demonstrates flexibility when confronted with emergencies, priority changes, or new assignments.
• Accepts other additional assignments and responsibilities to support the business.
• Ability to work independently and manage time effectively.
• Ability to work without direct supervision.

• No‑cost vision insurance, employer‑paid life insurance, paid company holidays, generous paid time off, sick leave,…