Position Overview
As a Document Control Specialist, you will sustain the change control system and support all Document Control activities in accordance with Dexcom's processes, 21 CFR Part 820 and ISO *****.
Competency in Microsoft Office and proficiency in generating reports to support Quality Assurance systems are required.
Critical thinking to resolve issues and a detail-oriented approach are essential.
Shift Pattern
Fixed (non-rotational) evening shift: Monday-Thursday 15:*****:00, 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 required training.
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 provide possible solutions based on job understanding.
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 SOPs.
Support the development of documentation and configuration control procedures.
Support 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.
Proficiency with Microsoft Office Suite.
Ability to create reports in support of other QA systems.
Critical thinking and issue resolution skills.
Knowledge of electronic documentation systems.
Ability to apply acquired knowledge of GDP and GMP to daily tasks.
Education & Experience
Minimum of 4–6 years of related experience and a Level 6 diploma/certificate in quality or a related area of study.
Benefits
A front-row seat to life-changing CGM technology.
Learn about our brave #dexcomwarriors community.
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 employees, customers and the communities we serve.
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