Document Control and Validation Specialist

Career-defining. Life-changing. 

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

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 develop and maintain validation documentation (test plans, test scripts, validation plan and reports).

Responsibilities: 

• Responsible for coordination of 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 complaint and timely manner.
• Responsible for the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control.
• Supports internal and external audits in backrooms, and helps with the coordination of document requests.
• Maintains quality records per applicable SOPs.
• Responsible for coordinating document change orders, collaboration, approval, release, archival and retention.
• Closely work with Training coordinator to ensure change orders are triggering training as required
• Develop and maintain validation documentation (test plans, test scripts, validation plan and reports)
• Support implementation of QMS systems, dashboards, or process changes through validation testing
• Design, build, and maintain dashboards and recurring reports
• Collaborate with cross-functional teams to understand reporting needs

Other duties may be assigned as deemed necessary by management

 

Responsibilities: 

• Responsible for coordination of 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 complaint and timely manner.
• Responsible for the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control.
• Supports internal and external audits in backrooms, and helps with the coordination of document requests.
• Maintains quality records per applicable SOPs.
• Responsible for coordinating document change orders, collaboration, approval, release, archival and retention.
• Closely work with Training coordinator to ensure change orders are triggering training as required
• Develop and maintain validation documentation (test plans, test scripts, validation plan and reports)
• Support implementation of QMS systems, dashboards, or process changes through validation testing
• Design, build, and maintain dashboards and recurring reports
• Collaborate with cross-functional teams to understand reporting needs
• 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 
• Strong attention to detail and data validation skills
• Computer Skills: software proficiency in Microsoft Office Suite is required
• Proficiency in Excel (advanced formulas, pivot tables)
• Experience with BI tools (Tableau, Power BI, or similar)
• Strong attention to detail and data validation skills
• Previous Veeva 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
• Experience in reporting, data analysis, or business intelligence
• 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 8:00 pm-5:00 am)

Location:

Manila

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121