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Quality & Compliance Specialist

hace 11 días

Springfield

Job Description Welcome to Apothékary™ , where Nature is Medicine™. We harness the intelligence of nature by creating clean, effective herbal remedies that target the root cause of health imbalances like helping to ease stress, support the gut, strengthen immunity, boost energy, and sharpen mental focus. Our herbal formulas feature traditional herbs from several medicinal modalities including Ayurveda, traditional Chinese medicine (TCM), Japanese Kampo, and Western herbalism. We believe in getting to the root cause of health issues and herbs can be a great place to start your journey and promote wellness for the long-term. We were founded in early 2019 by Shizu Okusa, a serial entrepreneur in the wellness industry and named E&Y’s Entrepreneur of the Year 2021. After leaving an intense finance career, she became inspired to live a more balanced lifestyle and revisit her Japanese roots and passion for herbal medicine. Shizu set out to help others regain their holistic health using traditions she grew up with and ones she learned along the way. Why work with us? • You will get the chance to be an early team member at a fast-growth health & wellness startup disrupting the intersection of food and medicine – preventative healthcare rooted in herbal medicine, • We are growing fast (100x growth in two years, over $16M in capital raised, and quadrupled the size of the team in the last 9 months), • We’re a tight-knit, passionate team, where you'll learn a ton and have ownership over your responsibilities., • Work with a seasoned second-time founder and executive team The role: The Quality & Compliance Specialist plays a critical role in maintaining and advancing Apothékary'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 report directly to our Director of R&D. Responsibilities: Quality Assurance: • 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. 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: • 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 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, • 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 Bonus points: • Previous experience with dietary supplement regulatory affairs, • Registered herbalist with the American Herbalist Guild, • Experience at a high-growth, fast-paced startup, • Entrepreneurial mindset Time and Location: The role is a hybrid role. Candidate must be available to work out of our Fulfillment Center in Lorton, VA. Our team primarily works off of Eastern Time between 9:00am-5:00pm. Some flexibility will be allowed between those hours, but this role will work closely in collaboration with the full time team and therefore would be expected to work between those regular daytime hours. This position is available to start immediately. Note that job responsibilities may change based on the company’s evolving needs. Apothékary is committed to building a diverse and inclusive team where everyone can thrive and contribute to our shared mission. We encourage candidates from all backgrounds to apply. Benefits Compensation: • Full-time (40 hours per week), • Salary range: $60,000 - $70,000, depending on experience, • Comprehensive health, dental and vision plans, • Monthly paid Mental Health Days in addition to PTO, • Monthly Apothékary product stipend

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