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Quality Assurance Associate II

Celldex
September 03, 2026
Full-time
Remote friendly (Fall River, MA)
Worldwide
Operations
Role: Quality Assurance Associate II supporting GMP manufacturing documentation activities to ensure compliance with GxP standards. Responsibilities: manage electronic document workflows, review and format GMP documents, support batch record and raw material release, maintain labeling and inventory, write/revise SOPs, conduct documentation audits, and support internal and external GMP audits. Also assist with training programs and off-site storage organization. Requirements: Associate degree with 2+ years GMP experience or 4+ years GMP experience without a degree; GMP documentation and GxP knowledge; proficiency in MS Office and EDMS; strong organizational skills and ability to prioritize. Preferred: GMP document management experience. High-Value: GMP manufacturing, GxP compliance, documentation, audit support, training, GMP environment. WorkSetup: not specified, likely on-site.