Specialist, QA Systems

Summary

The Specialist will perform moderately complex quality systems activities in a GxP-regulated pharmaceutical environment, managing processes such as deviations, CAPA, change control, vendor management, document control, and product complaints. Responsibilities include day-to-day QA administrative and operational tasks, electronic quality systems (QMS/LMS) support, SOP maintenance, audit readiness coordination, and routine reporting. The role requires strong attention to detail, data integrity focus, cross-functional collaboration, and working knowledge of FDA, ICH, GxP, GMP, GLP, and GCP regulatory frameworks.