Quality Documentation Specialist

Role: Documentation SpecialistLocation: RemoteJob Overview: Our client is seeking a Documentation Specialist responsible for managing, reviewing, and controlling documentation processes within a regulated environment. This role ensures full compliance with FDA Quality System Regulations (QSR), timely processing of controlled documents, and smooth administration of the Windchill change process.ResponsibilitiesManage and administer the Windchill change process, ensuring proper handling of Change Requests and Change Notices (CRs/CNs).Ensure documentation practices comply with FDA Quality System Regulations (QSR) and applicable internal procedures.Coordinate project activities, track timelines, and maintain effective communication with cross-functional teams.Maintain project tracking, reporting, and documentation updates.Oversee the timely processing, review, and release of new or updated controlled documents.Review CRs/CNs for completeness, accuracy, and adherence to required policies.Work closely with team management and change owners to prioritize documentation workflows.Provide updates on document change status as requested.Support the Periodic Review cycle of controlled quality documents.Retrieve and provide historical or current documentation to stakeholders when needed.Follow all SOPs, Work Instructions, Training Guides, and approved documentation tools.Assist with special projects and additional tasks assigned by Documentation Management leadership.Utilize Microsoft Office tools (Word, Excel, PowerPoint) efficiently for documentation and reporting tasks.