Quality and Compliance Specialist

The Quality & Compliance Specialist plays a critical role in maintaining and advancing Apothekary's quality management systems and regulatory compliance programs. This position is responsible for ensuring all products, processes, and operations meet or exceed industry standards, regulatory requirements, and company quality objectives. The ideal candidate will have a strong foundation in dietary supplement regulations, quality systems, and a meticulous attention to detail. This role will support and execute quality and compliance programs under the direction of the Director of R&D and Regulatory Affairs. Quality Assurance: 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 Certification Management: 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 Regulatory Compliance: 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 Training & Quality Culture 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