BIOptimizers · 1 month ago
QA/Compliance Specialist - Wellness and Consumer Brands
United States
Full-time
Hybrid
Mid Level
3+ years expBiOptimizers is dedicated to enhancing individuals' health through scientifically-backed supplements. The QA/Compliance Specialist is responsible for ensuring product quality and regulatory compliance, reviewing documentation, and supporting supplier qualifications to meet FDA and DSHEA standards.
FitnessHealth CareWellness
Responsibilities
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
Qualification
Required
Bachelor's degree in Life Sciences, Food Science, Chemistry, Biology, or related field required
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
Preferred
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., MasterControl, Greenlight Guru, TrackWise)
Knowledge of international supplement regulations (e.g., Health Canada, EU)
Company
BIOptimizers
Bioptimizers are supplements that help people attain optimal physical, mental, and spiritual well-being.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Trevor Newell
Chief Marketing Integrator
Recent News
2025-05-09
Company data provided by crunchbase