Change Control Specialist — Quality Systems & Compliance

Caris Life Sciences; Phoenix, Northern (AZ, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Caris Life Sciences seeks a Change Control Analyst to administer the Change Control process within the electronic Quality Management System (eQMS). You will coordinate records from initiation through closure, ensure regulatory compliance, and drive improvements across quality, regulatory, manufacturing, and operations teams.

The role involves facilitating impact assessments, monitoring progress, and preparing documentation for audits and inspections.

Qualifications

• 1–3 years of experience in a regulated quality environment.
• BS/BA in Life Sciences, Quality, Engineering, or related discipline.
• Experience working within an electronic Quality Management System (eQMS).
• Knowledge of quality system principles and change management processes.
• Proficient in 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.

Responsibilities

• Administer and maintain the Change Control system within the eQMS to ensure regulatory compliance.
• Coordinate lifecycle of change control records from initiation to closure.
• Review change control submissions for completeness and accuracy.
• Facilitate impact assessments with SMEs and cross-functional stakeholders.
• Monitor progress and ensure timely completion of deliverables and milestones.
• Support Change Control Board (CCB) governance meetings and document actions.
• Verify supporting documentation is linked and completed before closure.
• Generate and analyze change management metrics and trends.
• Prepare data for audits and regulatory inspections.
• Assist in investigating process delays and identify improvement opportunities.
• Provide guidance and training on change control procedures and regulatory expectations.

Skills

Communication skills

Organizational skills

Attention to detail

Time management

Education

BS/BA in Life Sciences, Quality, Engineering, or related

Tools

Microsoft Office

Job description

Caris Life Sciences seeks a Change Control Analyst to administer the Change Control process within the electronic Quality Management System (eQMS). You will coordinate records from initiation through closure, ensure regulatory compliance, and drive improvements across quality, regulatory, manufacturing, and operations teams.

The role involves facilitating impact assessments, monitoring progress, and preparing documentation for audits and inspections.