Change Control Analyst

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.

• 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.

At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care-we’re changing lives.

We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do.

But our mission doesn’t stop with cancer. We’re pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose.

Join us in our mission to improve the human condition across multiple diseases. If you’re passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins., Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation.

Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.