Change Control Analyst — Quality Systems & Compliance

Caris MPI, Inc.; Phoenix (AZ); On-site; USD 70,000 - 95,000; Full time

Job summary

Caris Life Sciences in Phoenix, AZ is seeking a Change Control Analyst to administer and coordinate the change control process within the electronic QMS, ensuring compliance with regulatory requirements and company procedures.

You will collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, IT, and other departments to assess impacts, prepare for audits, track metrics, and drive process improvements while maintaining rigorous documentation and timely

Qualifications

• 1–3 years in a regulated environment (Quality Systems/Change Control).
• BS/BA in Life Sciences or related discipline; equivalent experience may be considered.
• Experience in an electronic Quality Management System (eQMS).
• Knowledge of quality system principles and change management processes.
• Proficient in Word, Excel, Outlook, PowerPoint; strong organizational skills.
• Excellent written and verbal communication with attention to detail.

Responsibilities

• Administer and maintain the Change Control system within the eQMS to ensure compliance with regulatory requirements and quality standards.
• Coordinate the lifecycle of change control records from initiation through implementation and closure.
• Review submissions for completeness and adherence to procedures.
• Facilitate impact assessments with SMEs and cross-functional stakeholders.
• Monitor progress and ensure timely completion of deliverables and milestones.
• Support Change Control Board meetings with agenda, records, and actions.
• Verify required documentation is linked and completed prior to closure.
• Prepare and analyze change management metrics for audits and improvements.
• Assist in handling audits and regulatory inspections; provide training to stakeholders.

Skills

Quality Systems

Change Control

eQMS

Regulatory Affairs

Documentation Control

Communication

Education

BS/BA Life Sciences

Tools

Microsoft Office

Job description

Caris Life Sciences in Phoenix, AZ is seeking a Change Control Analyst to administer and coordinate the change control process within the electronic QMS, ensuring compliance with regulatory requirements and company procedures.

You will collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, IT, and other departments to assess impacts, prepare for audits, track metrics, and drive process improvements while maintaining rigorous documentation and timely