Document Control Specialist

This role maintains and manages the update, review, release, and storage of controlled documents, including policies, SOPs, and batch records, to ensure compliance with ISO, FDA, IVDR, CAP/CLIA, and GMP requirements. The specialist utilizes MasterControl to manage workflows, conduct audits, and ensure regulatory standards are met within the PharmaDx department. The position also involves training staff, assisting with audits, and collaborating with subject matter experts to prepare and review controlled documentation.