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Kalon Search4 weeks ago

Quality Assurance Manager

$100,000–$110,000 year

On-site · Colorado, United States

Type
Full Time
Level
Senior Level
Education
Not Specified
Company size
Unknown

Job Summary

Lead and scale quality systems across manufacturing, supplier oversight, compliance, and product release. Maintain cGMP and 21 CFR Part 111 compliance; oversee contract manufacturers and suppliers; review and approve MMRs, BPRs, COAs, and lot release decisions; manage deviations, CAPA, complaints, adverse events, and recall readiness; support label, packaging, and claims review with cross-functional teams; lead audit readiness across FDA, retailer, and third-party certifications; coordinate third-party testing and quality training initiatives; ensure audit-ready quality systems across all active SKUs; strong supplier and manufacturing accountability; consistent, timely lot release and batch review; effective CAPA, complaint handling, and recall preparedness.

Required Qualifications

  • 5+ years of QA experience in dietary supplements, functional foods, or natural products
  • Strong knowledge of 21 CFR Part 111 and cGMP requirements
  • Experience with contract manufacturing oversight and supplier qualification
  • Strong documentation, investigation, and root cause analysis skills
  • FDA audit or third-party certification experience preferred
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$100k – $110k / yr

Quality Assurance Manager · Kalon Search

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