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 position involves using MasterControl to manage document workflows, conduct audits, and ensure regulatory standards are met within the PharmaDx department. The specialist also provides training, assists with audits, and collaborates with subject matter experts to prepare and review controlled documents.