About this Document Control Specialist role at iRhythm Technologies
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:
iRhythm Technologies, Inc. is a is a publically 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. iRhythm 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.
Responsible for overall coordination of controlled documents within iRhythm’s global Document Control system
Maintain and improve processes associated with an electronic document control system within MasterControl Ensures timely completion and version control of all new and revised documentation
Work cross functionally to ensure change orders are executed in a timely manner
Responsible to 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
Aids in the responses to internal and external audits as they related to the Document Control process
Supports users requests for documents
Performs self-audits of satellite controlled binders, and ensures that current revision is available at point-of-use in a timely manner
Maintains quality records per applicable SOPs
Responsible for coordinating document change orders (packets), collaboration, approval, release and retention.
Other duties may be assigned as deemed necessary by management
Required Qualifications:
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
Through 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
This is a full time position. We offer an excellent benefit and salary package.
Location:
Remote - ManilaAs 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 [email protected]
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 [email protected]. 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