Specialist I, QA

The Quality Specialist is responsible for supporting and maintaining the site Quality Management System (QMS) to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements (21 CFR 211), and internal quality standards. This role leads investigations, customer complaints, manages CAPA systems, supports validation activities, and serves as a subject matter expert during audits. The Quality Specialist partners cross-functionally with Operations, Regulatory, and technical teams to drive continuous improvement, ensure product quality, and maintain data integrity in accordance with ALCOA+ principles.