Quality Specialist

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 a Quality 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 in food, dietary supplements, medical nutrition, pharmaceutical, nutraceutical, or contract manufacturing environments.
• Experience with SAP, Veeva, PLM, TraceGains, or similar quality/specification management systems preferred.
• Knowledge of FDA 21 CFR Part 111/117, HACCP, HARPC, and product release controls preferred.
• Bachelor's degree or equivalent experience in Quality, 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.
• Strong Excel and Microsoft Office skills, including managing trackers, dashboards, and structured data.