Document Control Specialist

The Document Control Specialist is responsible for managing the Document Control System in compliance with SOPs, overseeing the eQMS Document Control systems, and ensuring adherence to internal procedures, GMPs, and regulatory requirements. The role involves managing the training program related to controlled documents and internal training, providing QA support for change control, document control, training, eQMS validation, audits, and regulatory inspections. Responsibilities include serving as the primary Document Control/eQMS administrator; establishing and executing Document Control procedures; updating, reviewing, and approving controlled documents; and maintaining ISO standards and the Supplier Management Program database. Requirements include an Associate’s degree or equivalent, 3+ years of experience in document processing/document management in a medical device or pharmaceutical company, experience with Arena, Windchill, or Agile document control systems, and knowledge of ISO standards and FDA regulations.