Document Control and Validation Specialist

About This Role

The Document Control and Validation Specialist is responsible for managing and implementing the process associated with creation and revision of iRhythm’s Marketing documents and developing and maintaining validation documentation (test plans, test scripts, validation plan and reports).

Responsibilities

• Coordinate controlled documents within iRhythm’s global Marketing system.
• Maintain and improve processes associated with an electronic MLR system within the eQMS.
• Work cross-functionally to ensure change orders are executed in a compliant and timely manner.
• Ensure the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control.
• Support internal and external audits in backrooms, and help coordinate document requests.
• Maintain quality records per applicable SOPs.
• Coordinate document change orders, collaboration, approval, release, archival and...