Change Control Analyst

Caris Life Sciences • Phoenix, AZ

6d • Onsite

About The Position

At Caris, we are dedicated to transforming cancer care and improving lives through precision medicine. We are looking for a Change Control Analyst to manage the Change Control process within our electronic Quality Management System (eQMS). This role is crucial for ensuring that all proposed changes are properly assessed, evaluated, approved, implemented, and closed in compliance with regulatory requirements and company procedures. You will support various teams, including quality, regulatory, laboratory, manufacturing, and operations, by facilitating change management, maintaining data integrity, monitoring performance, and driving process improvements. Join us in our mission to improve the human condition and be part of a revolution in healthcare.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions ) and reference verification.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level