Senior QA Specialist – Clinical Lab Compliance

Tempus AI, Inc.; Chicago (IL); On-site; USD 55,000 - 100,000; Full time

Job summary

Tempus AI, Inc. is seeking a Quality Assurance Specialist or Senior Quality Assurance Specialist to document and track compliance for a clinical molecular laboratory. This role supports QA activities under FDA QMSR, ISO 13485, and global regulations, including CLIA/CAP requirements.

The position involves document control, material acceptance, and collaboration with management and testing personnel to ensure quality standards are met. Illinois-based salary ranges and flexible benefits are noted.

Qualifications

• Bachelor's Degree in Life Science or Engineering.
• 2-4 years of experience in industry or Quality.
• Highly organized and systematic, with superb attention to detail.
• Ability to complete repetitive tasks with a high degree of precision and accuracy.
• Proven ability to learn new skills quickly and adapt to new processes smoothly.
• Excellent time management and communication skills.
• Self-driven and works well in a fast-moving, cross-functional team environment with minimal direction.
• Ability to create processes and workflows, as well as define and create solutions to challenges.
• Intermediate computer skills and software applications, including experience with Microsoft Office tools and/or Google Suite applications.

Responsibilities

• Compile and approve the Device History Record.
• Complete incoming material acceptance activities.
• Read, understand, and update SOPs within the document control system; create/revise internal SOPs.
• File quality documentation in an organized manner.
• Maintain documentation to satisfy CLIA/CAP/NYS-DOH/FDA requirements.
• Provide metrics to identify trends and perform root cause analysis.
• Assist in audits by pulling records and reporting findings.
• Help implement corrective and preventative actions.

Skills

Attention to detail

Time management

Communication

Self-driven

Process design

Cross-functional teamwork

Quality mindset

Education

Bachelor's Degree in Life Science or Engineering

Job description

Tempus AI, Inc. is seeking a Quality Assurance Specialist or Senior Quality Assurance Specialist to document and track compliance for a clinical molecular laboratory. This role supports QA activities under FDA QMSR, ISO 13485, and global regulations, including CLIA/CAP requirements.

The position involves document control, material acceptance, and collaboration with management and testing personnel to ensure quality standards are met. Illinois-based salary ranges and flexible benefits are noted.