Apothékary™

Quality and Compliance Specialist

Apothékary™

full-time

Posted on:

Location Type: Hybrid

Location: Lorton • Virginia • United States

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About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
cGMP complianceSOP developmentroot cause analysisstability testingquality evaluationspackaging quality checksregulatory submissionsadverse event reportingtraining program developmentproduct documentation
Soft Skills
communication skillstime managementanalytical skillsproblem-solving skillscollaborationorganizational skillsleadershipattention to detailadaptabilityteamwork
Certifications
Non-GMOOrganicGluten-FreeCruelty-Free