Quality Documentation Specialist

Role: Documentation Specialist

Location: Remote

Job Overview:

Responsibilities

• Manage 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.