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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Change Control Analyst - **Company:** Caris Life Sciences - **Location:** Phoenix, AZ, United States - **Experience:** Starter - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Application Lifecycle Management, Microsoft Outlook, Data Centers, Data Integrity, Document Management Systems, Microsoft Office, Microsoft PowerPoint, Information Technology, Trackwise, Veeva, Mdsap - **Published:** September 3, 2026 - **Apply:** https://www.phoenixjobs.com/job.asp?id=3373880589&tx=JK10599LFU&pt=1&aff=0B19D771-A501-4A5E-8338-2A822B784D54&utm_source=Job%20Feed&utm_medium=textkernel&utm_campaign=DE&utm_term=0B19D771-A501-4A5E-8338-2A822B784D54 ## About the Role * 1-3 years of experience in Quality Systems, Change Control, Quality Assurance, Document Control, Regulatory Affairs, Manufacturing, or a related regulated environment. * BS/BA in Life Sciences, Quality, Engineering, or a related discipline; equivalent experience may be considered. * Experience working within an electronic Quality Management System (eQMS). * Knowledge of quality system principles and change management processes. * Proficient in Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint. * Strong organizational skills with the ability to manage multiple priorities and deadlines. * Excellent written and verbal communication skills. * Strong attention to detail and ability to maintain accurate records., * Experience administering change control records within systems such as Dot Compliance, MasterControl, Veeva, TrackWise, or equivalent eQMS platforms. * Working knowledge of FDA regulations, 21 CFR Part 820/QMSR, ISO 13485, ISO 15189, CAP, CLIA, EU IVDR, and MDSAP requirements. * Experience facilitating risk assessments and impact assessments. * Knowledge of validation, qualification, software lifecycle management, and training management processes. * Experience supporting regulatory inspections and quality audits. * Strong analytical skills with the ability to develop and present metrics and trend analyses. * Ability to interpret regulations and quality standards and apply them to change control decisions. * Experience participating in continuous improvement and operational excellence initiatives. Physical Demands * Employee may be required to lift up to 30 pounds. * Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes, and bio-hazardous material in the lab environment. ## Description The Change Control Analyst is primarily responsible for the administration, coordination, and management of the Change Control process within the electronic Quality Management System (eQMS). This role ensures that proposed changes are appropriately assessed, evaluated, approved, implemented, and closed in compliance with applicable regulatory requirements and company procedures. The Change Control Analyst supports quality, regulatory, laboratory, manufacturing, and operational teams by facilitating change management activities, maintaining data integrity, monitoring key performance indicators, and driving process improvements., * Administer and maintain the Change Control system within the eQMS to ensure compliance with applicable regulatory requirements and quality standards. * Coordinate the lifecycle of change control records from initiation through implementation, effectiveness verification, and closure. * Review change control submissions for completeness, accuracy, and adherence to procedural requirements. * Facilitate impact assessments with Subject Matter Experts (SMEs) and cross-functional stakeholders, ensuring appropriate evaluation of regulatory, quality, validation, training, manufacturing, laboratory, and business impacts. * Monitor change control progress and proactively follow up with record owners to ensure timely completion of deliverables and milestones. * Support Change Control Board (CCB) or equivalent governance meetings through agenda preparation, record presentation, tracking of decisions, and documentation of actions. * Verify that required supporting documentation (e.g., validation, risk assessments, training, CAPAs, document revisions, regulatory filings) is appropriately linked and completed prior to closure. * Generate and analyze change management metrics, including cycle times, aging records, overdue tasks, throughput, and closure trends. * Prepare change control data and supporting documentation for internal audits, external audits, client audits, and regulatory inspections. * Assist in investigating process delays and identify opportunities to improve change control efficiency and effectiveness. * Provide guidance and training to stakeholders on change control procedures, system usage, and regulatory expectations. * Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, Information Technology, and other departments to ensure effective implementation of changes. * Support periodic reviews of change management procedures and recommend process improvements based on industry best practices and regulatory expectations. * Maintain electronic and physical records associated with change control activities in accordance with record retention requirements., * All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. ## Related Videos - [Crew Management System for Airlines: Plan duties for pilots & flight attendants worldwide](https://www.wearedevelopers.com/videos/1444-crew-management-system-for-airlines-plan-duties-for-pilots-flight-attendants-worldwide) - [Reporting Active Exploits in 24 Hours: Are You Ready for the CRA?](https://www.wearedevelopers.com/videos/100248-reporting-active-exploits-in-24-hours-are-you-ready-for-the-cra) - [Agile work at CARIAD – Creating a customer web application for controlling the vehicle ](https://www.wearedevelopers.com/videos/200-agile-work-at-cariad-creating-a-customer-web-application-for-controlling-the-vehicle) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [System change: restart as developer?](https://www.wearedevelopers.com/magazine/39-system-change-restart-as-developer) - [From developer to manager – what does it take to become an engineering manager?](https://www.wearedevelopers.com/magazine/42-from-developer-to-manager-what-does-it-take-to-become-an-engineering-manager) - [Navigating the AI Shift](https://www.wearedevelopers.com/magazine/629-navigating-the-ai-shift) - [How to Make a Career Change to a Software Engineer Role](https://www.wearedevelopers.com/magazine/11-how-to-make-a-career-change-to-a-software-engineer-role)