Document Control Specialist

OVERALL RESPONSIBILITIES:

• Accountable for administration of the Windchill change process.
• Accountable for compliance with the Food and Drug Administration's (FDA) Quality System Regulation (QSR) as it pertains to Documentation and Documentation Control.
• Coordinate project activities and maintain timelines
• Provide project tracking, reporting, and communications
• Accountable for the timely processing and release of new and changed controlled documents.
• Proficient with Microsoft office: Word, Excel, and PowerPoint

POSITION DUTIES & RESPONSIBILITIES:

• Accountable that Change Requests and Change Notices(CRs/CNs) are reviewed for completeness, accuracy and compliance with applicable policies and procedures.
• Coordinate workflow and DePuy Synthes priorities of Document Management with team management and Change Owners on an as needed basis.
• Communicate change status information as requested.
• Support the Periodic Review process for controlled Quality documents
• Provide historical and current documentation in response to queries from management and other departments as needed.
• Properly employ all SOPs, Work Instructions, Training Guides, and Forms in the performance of tasks.
• Perform other special projects and support functions as assigned by the Manager and/or Supervisor of Document Management.