Clinical QA Specialist — Precision Medicine Lab

Tempus AI, Inc.; Chicago (IL); On-site; USD 27,000 - 45,000; Full time

Job summary

Tempus AI, Inc. is seeking a Senior Quality Assurance Associate or QA Specialist to document and track compliance for a clinical molecular laboratory. The role supports QMS activities in line with FDA QMSR, ISO 13485, and applicable global regulations.

The position offers shifts Sunday-Thursday or Tue-Saturday, with responsibilities spanning device history, SOP compliance, document control, and supplier certifications. Illinois pay range and comprehensive benefits are included.

Qualifications

• High school diploma or a Bachelor's degree in Life Science or Engineering preferred.
• 0-2 years of experience in industry or Quality or with clerical/documentation handling.
• 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.

Responsibilities

• Compilation of the Device History Record.
• Read and understand SOPs within the document control system.
• File quality records in a systematic organized manner.
• Maintain documentation in order to satisfy CLIA/CAP/NYS-DOH/FDA requirements.
• Aid in tracking and maintenance of quality records, including batch records, checklists, and quality and equipment binders.
• Report significant deviations and system deficiencies to management, under guidance and as appropriate.
• Pull records and reports as requested during internal and external audits.
• Help facilitate and implement corrective and preventative actions.
• Assist in document control workflow, as needed.
• Manage Supplier Documentation and Compliance, as needed: Proactively work with suppliers to ensure documentation on file is up to date.
• Send and Review Supplier Questionnaires.
• Maintain supplier certificates.
• Review and elevate customer and supplier notifications.
• Review documents received and elevate any concerns for further review.
• Review and elevate any concerns for further review.
• Help facilitate corrective and preventative actions.

Skills

Attention to detail

Time management

Communication skills

Adaptability

Documentation

Education

Bachelor's degree in Life Science or Engineering

High school diploma

Tools

Microsoft Office

Google Suite

Job description

Tempus AI, Inc. is seeking a Senior Quality Assurance Associate or QA Specialist to document and track compliance for a clinical molecular laboratory. The role supports QMS activities in line with FDA QMSR, ISO 13485, and applicable global regulations.

The position offers shifts Sunday-Thursday or Tue-Saturday, with responsibilities spanning device history, SOP compliance, document control, and supplier certifications. Illinois pay range and comprehensive benefits are included.