QA / Regulatory Affairs Specialist

Location: Greater New York City area | Working arrangement: On site | Industry: Nutraceuticals, Dietary Supplements and Nutritional Ingredients

About the role

This is a broad, hands‑on role covering quality assurance, quality control and regulatory compliance. The successful candidate will support day‑to‑day quality activities while working closely with operations, warehouse teams, suppliers, laboratories and customers.

Key Responsibilities

• Maintain regulatory registrations, licences and certifications required for the business.
• Support FDA, state and federal regulatory compliance activities.
• Maintain Organic certification and support updates to related regulatory documentation.
• Manage import permits and documentation for regulated ingredients and materials.
• Review product documentation and support QA/QC approval prior to product release.
• Review third‑party laboratory results and issue Certificates of Analysis where required.
• Review ingredient and product safety using a risk‑based approach.
• Manage customer complaints, non‑conformances and CAPA activities through the Quality Management System.
• Support supplier qualification and Foreign Supplier Verification Program (FSVP) activities.
• Review supplier quality and regulatory documentation.
• Conduct supplier and warehouse audits when required, including occasional travel.
• Support third‑party laboratory qualification, testing protocols and analytical result review.
• Complete customer and supplier quality questionnaires.
• Evaluate shelf‑life extensions using stability data, retesting information and manufacturer documentation.
• Support recall planning and maintain appropriate quality procedures and records.
• Maintain and update SOPs, quality policies and controlled documentation.
• Support the day‑to‑day maintenance of the electronic Quality Management System.
• Review warehouse quality records including temperature monitoring, pest control and calibration activities.
• Support repacking and sampling activities to ensure product quality, traceability and labeling accuracy.
• Deliver quality and compliance training to operations and warehouse teams.
• Monitor FDA communications and relevant industry standards to remain aware of emerging compliance requirements.

Candidate Profile

• Experience within dietary supplements, nutraceuticals, food ingredients, functional ingredients or a closely related regulated industry.
• Previous experience within Quality Assurance, Quality Control, Regulatory Affairs or a combined quality and regulatory role.
• Working knowledge of FDA requirements relating to food ingredients or dietary supplements.
• Experience reviewing Certificates of Analysis, specifications and laboratory testing results.
• Familiarity with CAPA, non‑conformances, customer complaints and supplier quality.
• Experience working within a formal Quality Management System.
• Knowledge of Organic certification, FSVP, supplier qualification or import compliance would be beneficial.
• Strong documentation, organization and communication skills.
• The ability to work independently while collaborating closely with operations, supply chain and commercial teams.
• Must live within a commutable distance of the Greater New York City area.
• This position is not eligible for visa sponsorship.