A well-established nutritional ingredients company is seeking a QA / Regulatory Affairs Specialist to join its Quality Assurance and Regulatory Affairs function and support a variety of quality, regulatory, and compliance activities.

Experience within the food, nutritional ingredients, dietary supplement, or a related regulated industry is preferred; however, candidates with relevant QA and regulatory experience from other industries may also be considered.

Key Responsibilities

Regulatory & Licensing

Maintain and renew FDA Food Facility Registration.
Manage applicable state feed licensing, renewals, and related reporting requirements.
Manage Organic Certificate renewals and Organic System Plan (OSP) changes.
Obtain and maintain USDA-APHIS import permits for regulated materials.
Manage applicable cosmetics-related regulatory requirements, filings, and reporting.

Product Quality & Compliance

Participate in QA/QC review and approval of orders prior to product release.
Review third-party analytical results and issue Certificates of Analysis (CoAs).
Review product and ingredient safety using a risk-based approach.
Respond to quality-related inquiries from internal and external stakeholders.
Support shelf-life extension evaluations based on retest and stability data.
Maintain and update recall plans and related documentation.

Non-Conformance, Complaints & CAPA

Manage customer complaints through the Non-Conformance and Corrective and Preventive Action (NC-CAPA) process.
Track quality issues through root-cause investigation and resolution.

Supplier & Vendor Quality

Conduct Foreign Supplier Verification Program (FSVP) investigations for overseas suppliers.
Conduct second-party supplier audits domestically and internationally, as needed.
Review third-party laboratories and analytical results.
Assist with establishing third-party laboratory testing methods and protocols.
Complete customer and vendor questionnaires related to quality and regulatory compliance.

Quality Systems & Documentation

Support day-to-day use and maintenance of the company’s Quality Management System (QMS).
Update and maintain QMS records and documentation.
Develop and revise Standard Operating Procedures (SOPs) and quality-related policies.
Respond to customer and internal quality documentation requests.

Facility & Operational Quality

Review warehouse temperature logs, pest-control reports, and other quality-related records.
Maintain calibration schedules and coordinate equipment calibration.
Conduct internal warehouse audits and third-party public warehouse audits.
Support repacking, sampling, and labeling activities in accordance with established quality procedures.
Support other warehouse and operational quality activities as needed.

Training & Regulatory Support

Provide staff training on quality procedures, systems, and compliance requirements.
Provide training related to Organic regulations and ingredient handling requirements.
Monitor FDA warning letters and maintain applicable regulatory and industry reference standards.
Coordinate document certification, authentication, and notarization when required.

Qualifications

Relevant experience in Quality Assurance, Regulatory Affairs, food safety, or a related area.
Experience in the food, nutritional ingredients, dietary supplement, or related regulated industry is preferred.
Familiarity with FDA regulations and quality/regulatory compliance requirements.
Experience with FSVP, Organic certification, CAPA, QMS, SOPs, supplier quality, audits, and/or product release is preferred.
Strong organizational, analytical, problem-solving, and documentation skills.
Strong attention to detail.
Strong written and verbal communication skills.
Ability to work effectively with internal teams, suppliers, laboratories, customers, and other external parties.
Ability to work on-site in Purchase, NY at least four days per week.
Ability to travel domestically and internationally as needed.