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Quality Specialist

Apolis

Quality SpecialistWe 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 ResponsibilitiesCoordinate, 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.Qualifications1–3 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.

Vacancy posted 3 days ago
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