Quality and Compliance Specialist

Job description

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 protoc...