Talent.com
Quality & Compliance Specialist

Quality & Compliance Specialist

ApothékaryAlexandria, VA, US
30+ days ago
Job type
  • Full-time
  • Quick Apply
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
  • Serve as subject matter expert on quality and regulatory matters
  • Requirements

    Ideal candidate :

  • 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
  • Create a job alert for this search

    Compliance Specialist • Alexandria, VA, US

    Related jobs
    • Promoted
    • New!
    Compliance Specialist

    Compliance Specialist

    AHEADWashington, DC, US
    Full-time
    AHEAD is currently seeking a Compliance Specialist to join the Legal team and to help build out the compliance function, including providing counseling to AHEAD's business teams and stakeholders.Yo...Show moreLast updated: 14 hours ago
    • Promoted
    • New!
    Code Specialist III

    Code Specialist III

    Fairfax County GovernmentLorton, VA, United States
    Full-time
    Join Fairfax County and make a real difference! As a part The Department of Public Works and Environmental Services (DPWES), Wastewater Management (WWM) supports the mission and vision to create an...Show moreLast updated: 17 hours ago
    • Promoted
    Inventory Specialist

    Inventory Specialist

    Matern Staffing, Inc.Fredericksburg, VA, United States
    Full-time
    Matern Staffing is hiring a Bilingual Inventory Specialist at a national building materials supplier in Fredericksburg, VA. As an Bilingual Inventory Specialist, you’ll help keep the building supply...Show moreLast updated: 3 days ago
    • Promoted
    • New!
    Quality Compliance, Senior Manager

    Quality Compliance, Senior Manager

    AmgenWashington, DC, US
    Full-time
    Quality Compliance Senior Manager.Join Amgen's Mission of Serving Patients.At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients livin...Show moreLast updated: 1 hour ago
    • Promoted
    Source Performance and Quality Specialist - Mid Job#490

    Source Performance and Quality Specialist - Mid Job#490

    Allen Integrated SolutionsWashington, DC, US
    Full-time
    Source Performance and Quality Specialist (Mid).Define, execute, and analyze the results of complex studies of collection system performance. Respond to requests for studies from customers across th...Show moreLast updated: 30+ days ago
    • Promoted
    Chief Quality & Compliance Leader — Healthcare

    Chief Quality & Compliance Leader — Healthcare

    CINQCAREWashington, DC, United States
    Full-time
    A community health provider in Washington, D.Vice President of Quality to lead and oversee quality excellence across products and services. The ideal candidate will bring over 15 years of experience...Show moreLast updated: 1 day ago
    • Promoted
    Quality Systems Specialist

    Quality Systems Specialist

    LanceSoftManassas, VA, US
    Full-time
    Duration - 1 Year - Onsite Position Shift - 8AM - 4 : 30PM.Key Responsibilities Quality Systems & Compliance : Assist in leading and coordinating the resolution and completion of Deviations, CAPAs, ...Show moreLast updated: 7 days ago
    Configuration Management Specialist

    Configuration Management Specialist

    SiloSmashersArlington, VA, USA
    Full-time
    Quick Apply
    Configuration Management Specialist.This position is part of a proposal submission and is contingent upon contract award. Manage software and hardware configurations to ensure system integrity and c...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Assurance Specialist

    Quality Assurance Specialist

    Orbis CorporationWashington, DC, United States
    Full-time
    Seeking a highly skilled Quality Assurance (QA) Specialist with a strong background in Information Technology to support mission-critical systems and ensure compliance with DoD and NMCI standards.T...Show moreLast updated: 30+ days ago
    • Promoted
    Safety Specialist (NASA HQ)

    Safety Specialist (NASA HQ)

    LeidosSpringfield, VA, US
    Permanent
    Leidos has an exciting opportunity for a.NASA Headquarters (HQ) in Washington DC.Hygienist with building life safety and Indoor Air Quality (IAQ) experience to work with the best and brightest at N...Show moreLast updated: 30+ days ago
    • Promoted
    Insider Threat Program User Activity Monitor Sustainment Lead

    Insider Threat Program User Activity Monitor Sustainment Lead

    LeidosUpper Marlboro, MD, US
    Full-time
    The Digital Modernization Sector at Leidos currently has an opening for a User Activity Monitor (UAM) Sustainment Lead supporting the HEITS Contract as part of the Department of Homeland Security (...Show moreLast updated: 30+ days ago
    • Promoted
    Policy & Compliance Specialist

    Policy & Compliance Specialist

    LMI Consulting, LLCTysons, VA, United States
    Full-time
    Policy & Compliance Specialist.Salaried High Fringe / Full-Time.LMI is seeking a Policy & Compliance Analyst to support the development and execution of a compliance program at a national agency.The ...Show moreLast updated: 30+ days ago
    • Promoted
    Compliance Specialist

    Compliance Specialist

    Veterans StaffingWashington, DC, US
    Full-time
    The Compliance Specialist will work to ensure contract compliance of The Community Partnership for the Prevention of Homelessness (TCP) programmatic portfolio. In so doing, the Compliance Specialist...Show moreLast updated: 2 days ago
    • Promoted
    Laboratory Director ($10,000 SIGN-ON BONUS)

    Laboratory Director ($10,000 SIGN-ON BONUS)

    KA Recruiting Inc.Stafford, VA, US
    Full-time
    Are you looking for a new lab leadership position? My name is Caroline and I’m a healthcare recruiter – I’m here to help! . Monday-Friday, 8am-4pm, no weekends.Comprehensive b...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Compliance Specialist

    Senior Compliance Specialist

    LMI Consulting, LLCWashington, DC, United States
    Full-time
    Salaried High Fringe / Full-Time.LMI is seeking a skilled Senior Compliance Consultant to lead the development and execution of a compliance program at a national agency. The Senior Compliance Consult...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Quality Management Specialist

    Quality Management Specialist

    Maryland StaffingRockville, MD, US
    Full-time +1
    Key Role : Apply knowledge of GxP regulations and guidelines with specific emphasis on computer software assurance (CSA) and computer system validation (CSV). Leverage experience with an electronic Q...Show moreLast updated: 13 hours ago
    • Promoted
    SCIF Accreditation and Inspection Specialist

    SCIF Accreditation and Inspection Specialist

    AMERICAN SYSTEMSWashington, DC, United States
    Full-time
    AMERICAN SYSTEMS is an employee-owned federal government contractor supporting national priority programs through our strategic solutions in the areas of Information Technology, Test & Evaluation, ...Show moreLast updated: 5 days ago
    • Promoted
    Chief Quality & Compliance Leader - Healthcare

    Chief Quality & Compliance Leader - Healthcare

    CINQCAREWashington, DC, US
    Full-time
    A community health provider in Washington, D.Vice President of Quality to lead and oversee quality excellence across products and services. The ideal candidate will bring over 15 years of experience...Show moreLast updated: 23 hours ago