Hiring: Change Control Analyst Company: Caris Life Sciences Location: Phoenix, AZ Job Posted Time: 2026-09-03 14:20:59 Target Skills & Keywords : Change Management, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Quality Assurance About the job Experience: •1-3 years of experience in Quality Systems, Change Control, Quality Assurance, Document Control, Regulatory Affairs, Manufacturing, or a related regulated environment. •3 years of experience in Quality Systems, Change Control, Quality Assurance, Document Control, Regulatory Affairs, Manufacturing, or a related regulated environment. Required Skills: •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. Qualifications: •BS/BA in Life Sciences, Quality, Engineering, or a related discipline; equivalent experience may be considered. •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. •Solid functional working knowledge of FDA regulations, 21 CFR Part 820/QMSR, ISO 13485, ISO 15189, CAP, CLIA, EU IVDR, and MDSAP requirements. •Knowledge of validation, qualification, software lifecycle management, and training management processes. •Strong analytical skills with the ability to develop and present metrics and trend analyses. •Demonstrated capacity to interpret regulations and quality standards and apply them to change control decisions. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!