Document Control and Validation Specialist

About This Role

The Document Control and Validation Specialist is responsible for managing and implementing the process associated with the creation and revision of iRhythm’s Marketing documents and developing and maintaining validation documentation (test plans, test scripts, validation plans 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 accuracy of documentation per approved SOPs, GMP and internal change control.
• Support internal and external audits and help coordinate document requests.
• Maintain quality records per applicable SOPs.
• Coordinate document change orders, including collaboration, approval, release, archival and retention.
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