Quality & Compliance Documentation Specialist

Position Overview The Quality & Compliance Documentation Specialist is responsible for collecting, reviewing, and maintaining all documentation received from overseas manufacturers related to finished dietary supplements and dietary ingredients. This role ensures that all Certificates of Analysis (COAs), test reports, specifications, and regulatory documents meet company standards, industry regulations, and product quality requirements. The specialist works closely with Quality Assurance, Regulatory Affairs, Supply Chain, and external manufacturing partners to ensure complete, accurate, and compliant documentation for every finished product.

WORK HOURS

This position is available only for the 7:30 AM - 4:00 PM shift. Key Responsibilities Documentation Management Collect, organize, and maintain all incoming documentation from overseas manufacturers, including COAs, batch records, specifications, allergen statements, and manufacturing declarations. Review documentation for completeness, accuracy, and compliance with company standards and regulatory requirements. Track missing, incomplete, or outdated documents and follow up with suppliers to obtain required information. Maintain digital and physical documentation archives in accordance with internal SOPs. Quality & Compliance Review Evaluate test reports for finished dietary supplements to ensure results meet established specifications. Verify that all required testing (microbial, heavy metals, identity, potency, stability, etc.) has been completed and properly reported. Identify discrepancies or non‑conformances in documentation and escalate issues to Quality Assurance leadership. Ensure supplier documentation aligns with

FDA 21 CFR

Part 111 (cGMP for dietary supplements) and other applicable regulations. Supplier Communication & Coordination Serve as the primary point of contact for overseas manufacturers regarding documentation requests and compliance requirements. Communicate corrective actions, missing information, or clarifications needed to complete product release. Support onboarding of new suppliers by collecting required regulatory and quality documentation. Cross‑Functional Support Collaborate with Regulatory Affairs to support label reviews, product registrations, and compliance submissions. Assist Supply Chain and Operations teams by providing timely documentation needed for product release and inventory movement. Support Quality Assurance in audits, investigations, and continuous improvement initiatives. System & Process Management Maintain documentation logs, trackers, and databases to ensure real‑time visibility of document status. Contribute to the development and improvement of SOPs related to documentation control and supplier compliance. Ensure all documentation is stored in accordance with internal retention policies. Qualifications Required 2-4 years of experience in documentation control, quality assurance, regulatory affairs, or supply chain within dietary supplements, food, pharmaceuticals, or related industries. Strong understanding of COAs, test reports, and manufacturing documentation. Familiarity with FDA cGMP regulations for dietary supplements (21 CFR Part 111). Excellent attention to detail and organizational skills. Strong communication skills, especially when working with overseas suppliers. Proficiency with Microsoft Office and document management systems. Ability to manage multiple priorities and deadlines. Clear and professional communication. Strong analytical and problem‑solving skills. Commitment to quality and regulatory compliance. Preferred Experience working with international manufacturers (China, India, South America, etc.). Knowledge of analytical testing terminology (HPLC, microbiology, heavy metals, etc.).

Pay:

$24.00 - $29.00 per hour

Benefits:

401(k) matching Disability insurance Health insurance Paid time off Parental leave

Work Location:

In person