QA​/Compliance Specialist - Wellness and Consumer Brands

About Bi Optimizers
At BiOptimizers, our mission is to move people from baseline health to peak biological performance. Rooted in scientific rigor, we design supplements and experiences that empower individuals to excel. Our remote-first team collaborates cross-functionally, blending innovation with results to magnify human potential.

The QA/Compliance Specialist plays a key role in ensuring that all products, raw materials, and manufacturing partners meet the company’s quality and regulatory standards. This position is responsible for reviewing and maintaining quality documentation, approving and monitoring suppliers, and ensuring compliance with the Dietary Supplement Health and Education Act (DSHEA), 21 CFR Part 111/117, and related FDA and FTC regulations.

• Review Certificates of Analysis (CoAs), master manufacturing records (MMRs), and batch production records (BPRs) from contract manufacturers for accuracy and completeness.

• Verify that all documentation complies with internal specifications, label claims, and DSHEA requirements for identity, purity, strength, and composition.

• Maintain comprehensive document control systems, including version management, retention, and archival of GMP documentation.

• Review finished product labels and marketing claims for DSHEA and FDA compliance.

• Support product release processes by ensuring that each lot meets established quality standards before distribution.

• Lead or support supplier qualification, approval, and requalification activities per company procedures and DSHEA/GMP standards.

• Evaluate supplier documentation, including GMP certifications, audit reports, questionnaires, and ingredient specifications.

• Maintain the Approved Supplier List (ASL) and track supplier performance, deviations, and corrective actions.

• Support audits of contract manufacturers and ingredient suppliers to verify compliance with GMP and DSHEA.

• Ensure all dietary supplement products are manufactured, labeled, and marketed in compliance with DSHEA, FDA, and FTC regulations.

• Maintain awareness of regulatory updates related to dietary supplements and communicate implications to internal stakeholders.

• Assist in managing adverse event reporting, product recalls, and regulatory inspections in alignment with DSHEA and company policy.

• Support development, review, and continuous improvement of SOPs, CAPAs, and change control processes.

• Partner with cross-functional teams to ensure product claims are substantiated and compliant with DSHEA structure/function requirements.

• Identify gaps in quality systems and recommend enhancements to strengthen compliance and operational efficiency.

• Support internal training programs on DSHEA, GMP, and quality standards to reinforce compliance culture across teams.

• Participate in internal audits and assist in readiness for FDA, NSF, or third‑party inspections.

• Education:
  
  Bachelor’s degree in Life Sciences, Food Science, Chemistry, Biology, or related field required.

  Experience:

  • 3–5 years of QA/compliance experience in the dietary supplement, nutraceutical, or pharmaceutical industry.

  • Demonstrated understanding of DSHEA, FDA cGMP (21 CFR Part 111/117), and related regulatory requirements.

  • Experience working with contract manufacturers and suppliers in a quality or compliance capacity.

• Strong attention to detail and organizational accuracy.

• Excellent written and verbal communication skills.

• Proficiency with document management systems and Microsoft Office Suite.

• Ability to interpret and apply DSHEA, GMP, and labeling regulations in practical business settings.

• Experience with regulatory submissions, structure/function claim substantiation, and label compliance review.

• Familiarity with NSF, UL, Non‑GMO, and Organic certification standards.

• Experience using electronic QMS or document control software (e.g., Master Control, Greenlight Guru, Track Wise).

• Knowledge of international supplement regulations (e.g., Health Canada, EU).

This is a fully remote position. BiOptimizers has a globally…