Change Control Specialist

3 weeks ago


Manila, National Capital Region, Philippines iRhythm Technologies, Inc. Full time

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Responsibilities:
  • Responsible for owning and leading the change control process to support engineering changes.
  • Provide document redlines based on engineering inputs.
  • Document change impact assessments, risk assessments, documenting change descriptions, and other administrative change control steps based on engineering inputs.
  • Supporting the document control team with updates needed on the change control process within MasterControl.
  • Work cross-functionally to ensure change orders are executed in a timely manner.
  • Responsible for the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control.
  • Supports internal and external audits, helps with the coordination of document requests.
  • Supports the request from users for documents and reports.
  • Technical writing skills with the capability to update documents based on inputs from engineering.
  • Other duties may be assigned as deemed necessary by management.
About You:
  • 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 2 years of experience in Document Management System.
  • Thorough 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 (8am-4:30pm in the PST timezone).
What's In It For You:

iRhythm GBS Philippines is committed to providing an exciting career path for every team member, with unlimited learning opportunities for you. Our key focus is to ensure a healthy and well-balanced work life, which is why we provide you with comprehensive health and life insurance benefits, with eligible dependent coverage. We offer a competitive compensation package and above industry standard paid leave benefits.

Seniority Level:

Associate

Employment Type:

Full-time

Job Function:

Administrative

Industries:

Medical Equipment Manufacturing

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