Change Control / Document Control Specialist

Overview:

Responsible for managing the Windchill change process and ensuring compliance with FDA Quality System Regulation (QSR) for Documentation and Document Control. This role supports change management, document processing, and coordination of related quality activities.

Key Responsibilities:

• Administer and manage the Windchill change control process.
• Review Change Requests and Change Notices (CRs/CNs) for completeness, accuracy, and compliance.
• Ensure timely processing and release of new or revised controlled documents.
• Coordinate document management workflows and project activities to maintain timelines.
• Provide project tracking, reporting, and communication updates.
• Support the periodic review of controlled quality documents.
• Retrieve and provide documentation for internal queries and audits.
• Follow all relevant SOPs, Work Instructions, and training materials.
• Perform additional tasks or projects as assigned.

Qualifications:

• Proficient in Microsoft Word, Excel, and PowerPoint.
• Strong attention to detail, organizational, and communication skills.
• Experience in document control within a regulated environment preferred.