Change Control Specialist

About This Role

Specific job responsibilities include:

• 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-430p 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. 

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