RCRA Compliance Manager
3E
Quality & Compliance Specialist
Apothékary™
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $45,000 - $50,000 per year
Job Level
JuniorMid-Level
About the role
- Maintain and continuously improve the company's Quality Management System (QMS) in accordance with cGMP requirements for dietary supplements (21 CFR Part 111)
- Develop, implement, and maintain Standard Operating Procedures (SOPs) for all quality-related activities including owning the organization and maintenance of all QA documentation: raw material COAs, formulation spec sheets, process parameters, QC and third-party test results, batch records, supplier verifications, and labeling requirements
- Manage quality issues across all products, leading investigations into out-of-spec concerns (e.g., color, flavor, sedimentation, sourcing discrepancies)
- Conduct root-cause analyses for quality deviations and provide R&D recommendations for rework, reformulation, or remediation
- Lead stability testing programs: design protocols, manage sample retention, track data, and deliver reports to support product shelf life and retailer documentation needs
- Conduct internal audits of manufacturing facilities, suppliers, and quality systems to ensure compliance with established procedures and regulatory requirements
- Proactively communicate with co-manufacturers to secure documentation, resolve quality issues, and ensure production standards are upheld
- Develop and oversee QA, regulatory, and fulfillment SOPs, integrating QC checkpoints into operational workflows to drive efficiency and compliance
- Support onboarding of new co-manufacturers by establishing quality control parameters, documentation requirements, and production standards
- 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
- Review and approve all product labeling for compliance with FDA/DSHEA standards and retailer requirements
- Monitor and interpret changes in federal, state, and international regulations affecting product portfolio
- Support product registration and notification requirements for various jurisdictions
- Collaborate with Creative and Regulatory leadership to develop compliant product claims that align with brand positioning and key reasons to believe (RTBs)
- Review all marketing assets (copy, visuals, campaigns) for herbal accuracy, product details, and compliant claims
- Prepare and submit required retailer documentation including product specs, 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 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 subject matter expert on quality and regulatory matters
Requirements
- Formal schooling, training, and certifications in herbalism, nutrition, or other alternative health modalities (2+ years)
- Experience in dietary supplement quality systems, including compliance with cGMP, raw material qualification, batch record review, stability testing, and product documentation
- Experience working for a dietary supplement manufacturer or brand
- Excellent verbal and written skills, for working with teams internally, co-manufacturer communication, and compliant blog writing for customers
- 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
- Salary range: $45,000 - $50,000 base salary depending on experience
- Eligibility for bonus
- 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
Quality Management System (QMS)cGMPStandard Operating Procedures (SOPs)root-cause analysisstability testinginternal auditsregulatory complianceadverse event reportingproduct registrationquality control parameters
Soft skills
communicationtime managementanalytical skillsproblem-solvingteam collaborationorganizational skillsleadershiptraining developmentattention to detailadaptability
Certifications
herbalism certificationnutrition certificationcGMP certificationNon-GMO certificationOrganic certificationGluten-Free certificationCruelty-Free certification
