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Quality Specialist

Apolis
  • 🇺🇸 United States
  • Remote
  • 17 hours ago
  • $30 – $35 / hour
  • Excel
  • SAP
  • Veeva
  • HACCP
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Job Title: Quality Specialist
Location: Bridgewater, NJ
Work Location: Remote
Schedule: Full-Time, Monday–Friday, 8:00 AM–5:00 PM

Position Summary

We are seeking aQuality Specialist to support U.S. Nutrition & Health Contract Manufacturing Quality. This role will coordinate and manage finished product specification updates for externally manufactured products, ensuring compliance with quality, regulatory, testing, labeling, and release requirements.

Key Responsibilities

  • Coordinate, track, and close specification updates, change controls, and quality-related requests.
  • Maintain master trackers for specification updates, priorities, affected SKUs/materials, contract manufacturers, and implementation dates.
  • Partner with contract manufacturers to confirm testing capabilities, methods, COA requirements, release criteria, and implementation readiness.
  • Support updates related to microbiological requirements, contaminants, allergens, claims, certifications, packaging, shelf life, and market-specific requirements.
  • Maintain controlled specifications, approval documentation, and supporting quality records in SharePoint or applicable quality systems.
  • Develop Excel dashboards and reports to monitor overdue updates, compliance gaps, launch risks, and implementation issues.

Qualifications

  • 1–3 years of experience in specification management, quality systems, data maintenance, or product release/testing requirements.
  • Experience infood, dietary supplements, medical nutrition, pharmaceutical, nutraceutical, or contract manufacturing environments.
  • Experience withSAP, Veeva, PLM, TraceGains, or similar quality/specification management systems preferred.
  • Knowledge ofFDA 21 CFR Part 111/117, HACCP, HARPC, and product release controls preferred.
  • Bachelor's degree or equivalent experience inQuality, Food Science, Regulatory, Chemistry, Microbiology, Nutrition, Supply Chain, or a related technical field preferred.
  • Strong understanding of specification lifecycle management, change control, document control, and data integrity.
  • Excellent written and verbal communication skills.
  • StrongExcel and Microsoft Office skills, including managing trackers, dashboards, and structured data.
#APOLIS2027


Quality Specialist · Apolis

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