Meet the Team
As a Document Control Specialist, you will be responsible for sustaining the change control system and supporting all Document Control activities in accordance with Dexcom's processes, 21 CFR Part 820 and ISO-*****.
Competent with Microsoft Office is a must for this position.
Proficient in generating reports to support other Quality Assurance systems.
The ability to use critical thinking and resolve issues is required.
A highly driven, detailed oriented person is essential for this position.
Knowledge of electronic documentation systems is required.
Shift Details
Fixed (non rotational) evening shift pattern:
Monday - Thursday 15:30 - Midnight
Friday 14:*******:00
Evening Shift Premium: 18%
Responsibilities
Manage the change control system.
Review, route and release change orders.
Assist in change control system software training and other training as required.
Ensure projects are completed accurately and on time.
Interact with internal and external customers.
Support Quality in both external and internal audits.
Monitor the status of in-process document changes to ensure timely revisions.
Assist customers with problem solving and offer possible solutions.
Scan, archive and retrieve quality documents and records.
Issue controlled and uncontrolled documents.
Maintain service records of all departments.
Prepare requests for reproduction of documents.
Maintain external standards in accordance with standard operating procedures.
Support the development of documentation and configuration control procedures.
Support the testing and improvement of the change control software and other supporting software.
Generate Quality Assurance reports as needed.
Qualifications
Good understanding of Document Control requirements and processes as outlined in ISO ***** and 21 CFR Part 820.
Proficient with Microsoft Office Suite.
Ability to create reports in support of other Quality Assurance systems.
Critical thinking and problem resolution skills.
Knowledge of electronic documentation systems.
Ability to apply acquired knowledge of GDP and GMP to daily tasks.
Experience and Education
Typically requires a minimum of 4-6 years of related experience and a minimum level 6 diploma/certificate in quality or a related area of study.
Benefits
A front row seat to life-changing CGM technology.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
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