Quality and Compliance Specialist

Role Overview

• Support the development and organization of quality systems and documentation aligned with cGMP requirements (21 CFR Part 111)
• Develop, implement, and maintain 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 (e.g., color, flavor, sedimentation), 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 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
• Perform packaging and labeling quality checks to ensure accuracy, compliance, and alignment with brand standards (e.g., label placement, lot coding, packaging condition)
• 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 (e.g., Non-GMO, Organic, Gluten-Free, Cruelty-Free, etc.), ensuring timely renewals and expansion into new certifications as aligned with company goals.
• Serve as primary liaison with certification bodies and auditors
• 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
• Monitor and interpret changes in federal, state, and international regulations affecting the product portfolio
• Support product registration and notification requirements for various jurisdictions
• 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
• Coordinate 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
• Serve 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
• Ability to work in a fast-paced, timeline-focused team environment
• Excellent time management skills with a proven ability to manage multiple priorities simultaneously
• Strong analytical and problem-solving skills
• Proficient with Microsoft Office and Google Suite or related software

Benefits

• Comprehensive health, dental and vision plans
• Monthly paid Mental Health Days in addition to PTO
• Monthly Apothékary product stipend