Quality and Compliance Specialist

Quality & Compliance Overview

The Quality & Compliance Specialist supports the development and maintenance of quality systems and regulatory compliance programs to ensure all products meet industry standards and regulatory requirements.

Responsibilities

• Support the development and organization of quality systems and documentation aligned with cGMP requirements (21 CFR Part 111)

• Develop, implement, and maintain Standard Operating Procedures (SOPs) across QA activities, including management of QA documentation (e.g., COAs, specifications, batch records, testing results, supplier documentation, and labeling requirements)

• Manage product quality issues, including investigation of out-of-spec results, root cause analysis, and recommendations for remediation

• Lead stability testing programs, including protocol design, sample management, data tracking, and reporting to support shelf life and retailer requirements

• Serve as a point of contact for internal, supplier, and certification audits, coordinating documentation and supporting Corrective Action Preventative Actions (CAPAs)

• Manage communication with co-manufacturers to ensure adherence to quality standards and resolution of documentation or quality issues

• Support onboarding of new co-manufacturers by establishing quality parameters and documentation requirements

• Conduct hands-on product quality evaluations, including inspection of finished goods for sensory and physical attributes

• Support on-site quality checks at fulfillment center and co-manufacturer locations as needed prior to product release or distribution

• Support final product review and release decisions in collaboration with internal stakeholders and co-manufacturers

• Manage certification strategy and applications, ensuring timely renewals and expansion into new certifications as aligned with company goals

• Coordinate annual audits, surveillance audits, and recertification activities

• Monitor regulatory changes affecting certifications and implement necessary updates

• Manage certified product lists and ensure accurate certification claims on labeling and marketing materials

• Support review of product labeling and marketing materials for compliance with FDA/DSHEA standards and retailer requirements

• Collaborate with Creative and Regulatory leadership to develop compliant product claims aligned with brand positioning and key reasons to believe (RTBs)

• Prepare and submit required retailer documentation, including product specifications, shelf life data, QA documentation, and compliance questionnaires

• Maintain adverse event reporting systems and ensure timely submission of required reports

• Cover responses to regulatory inquiries and support preparation of responses to warning letters, if applicable

• Support regulatory submissions for new products and formulation changes

• Develop and deliver quality and compliance training programs for employees, contractors, and co-manufacturers

• Maintain training records and ensure appropriate qualification of personnel

• Foster a culture of quality throughout the organization

• Support as a resource on quality and regulatory matters, escalating complex issues as needed

Requirements

• 3-5 years of experience in dietary supplement, food, or CPG quality, regulatory, or compliance roles
• Experience in dietary supplement quality systems, including cGMP compliance, raw material qualification, batch record review, stability testing, and product documentation
• Background in nutrition, food science, biology, chemistry, or related field, or equivalent practical experience
• Excellent verbal and written communication skills for cross-functional collaboration, co-manufacturer communication, and compliant content review
• Proven ability to manage multiple priorities simultaneously
• Strong analytical and problem-solving skills
• Proficient with Microsoft Office and Google Suite or related software