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Apothékary™ · 3 months ago

Quality & Compliance Specialist

Springfield, VA

Full-time

Hybrid

Entry, Mid Level

$60K/yr - $70K/yr

2+ years exp

Apothékary™ is a fast-growing health and wellness startup focused on creating herbal remedies. The Quality & Compliance Specialist is responsible for maintaining and advancing the company's quality management systems and ensuring regulatory compliance for all products and processes.

Retail

Responsibilities

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

Qualification

Dietary supplement regulationsQuality Management System (QMS)CGMP complianceStandard Operating Procedures (SOPs)Stability testingAnalytical skillsVerbal skillsMicrosoft Office proficiencyGoogle Suite proficiencyEntrepreneurial mindsetWritten skillsTime managementProblem-solving skills

Required

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

Preferred

Previous experience with dietary supplement regulatory affairs

Registered herbalist with the American Herbalist Guild

Experience at a high-growth, fast-paced startup

Entrepreneurial mindset

Benefits

Comprehensive health, dental and vision plans

Monthly paid Mental Health Days in addition to PTO

Monthly Apothékary product stipend

Company

Apothékary™

Apothékary started with our founder, Shizu Okusa, and her family’s traditional Japanese approach to healing — using nature as medicine instead of over-the-counter fixes.

Founded in 2020

Lorton, Virginia, US

51-200 employees