QA / Regulatory Affairs Specialist

CSG Talent; New York (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

CSG Talent partners with an established nutraceuticals company recruiting a Quality & Regulatory Specialist. The role spans QA, QC and regulatory compliance, supporting daily quality activities with operations, warehouses, suppliers and laboratories.

The ideal candidate has experience in dietary supplements or related regulated industries, and working knowledge of FDA requirements, CAPA and supplier quality. Occasional travel for audits may be required.

Qualifications

• Experience in dietary supplements, nutraceuticals, or closely related regulated industries.
• Background in QA, QC, regulatory affairs or a combined quality-regulatory role.
• Familiarity with FDA requirements relating to food ingredients or dietary supplements.

Responsibilities

• Maintain regulatory registrations, licenses and certifications.
• Support FDA, state and federal regulatory compliance activities.
• Maintain Organic certification and update related regulatory documentation.
• Manage import permits and documentation for regulated ingredients and materials.
• Review product documentation and support QA/QC approval prior to release.
• Review Certificates of Analysis and laboratory results when required.
• Manage recalls planning and CAPA within the Quality Management System.
• Assist supplier qualification and Foreign Supplier Verification activities.

Skills

Quality Assurance

Regulatory Affairs

FDA Requirements

Documentation

CAPA

Internal Audits

SOPs

Job description

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

We are partnering with an established business within the nutritional ingredients and dietary supplement sector to recruit a Quality & Regulatory Specialist.

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.

Candidates must be based within a commutable distance of the Greater New York City area and comfortable working on site.

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 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 labelling 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

The ideal candidate will have:

• 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, organisation 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.