Senior Document Control Specialist - Philippines, Pilipinas - iRhythm Technologies, Inc.

Paglalarawan

iRhythm Technologies, Inc. is a is a publicly held (Nasdaq: IRTC) medical device and healthcare information services company with a proven approach to long-term continuous monitoring that enables diagnosis earlier in the clinical pathway to improve patient outcomes and reduce healthcare costs. Rhythm provides competitive compensation and benefits package.

The Document Control Specialist is responsible for managing and implementing the process associated with creation and revision of iRhythm's Quality System documents. Responsible for maintaining a complaint change control process within the global Document Control System.

Responsibilities:

• Responsible for coordination of controlled documents within iRhythm's global Document Control system
• Maintain and improve processes associated with an electronic document control system within the eQMS.
• Work cross-functionally to ensure change orders are executed in a complaint and timely manner.
• Responsible for the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control.
• Supports the request from users for documents and reports in the eQMS
• Supports internal and external audits in backrooms, and helps with the coordination of document requests.
• Aids in the responses to internal and external audits as they related to the Document Control process.
• Maintains quality records per applicable SOPs.
• Responsible for coordinating document change orders (packets), collaboration, approval, release, archival and retention.
• Closely work with Training coordinator to ensure change orders are triggering training as required
• Other duties may be assigned as deemed necessary by management

Required Qualifications:

• Must have strong communication (verbal and written) and interpersonal skills
• Attention to detail and timeliness are critical
• Computer Skills: software proficiency in Microsoft Office Suite is required
• Previous MasterControl experience is highly desirable
• Must build rapport across functional teams within the organization
• Bachelor's Degree or equivalent experience
• Minimum of 5 years of experience in Document Management System or 2 years in Document Control and 3 years in applicable quality discipline
• Understanding of the regulations and regulatory processes for document control/ management
• Must operate through collaboration and transparency
• Experience in cGMP/GDP/GCP environments and FDA-regulated industries is preferred
• Must be available to work during the hours to support the business needs (tentatively 1:00 am - 10:00 am)

This is a full time position. We offer an excellent benefit and salary package.