Quality Assurance Associate – Genomics & Clinical Lab

Tempus AI, Inc.; Chicago (IL); On-site; USD 32,000 - 36,000; Full time

Benefits offered by this job

Benefits package

Incentive compensation

Restricted stock units

Medical benefits

Job summary

Tempus AI, Inc. is seeking a Senior Quality Assurance Associate to document and track compliance for a clinical molecular laboratory. You will support QA activities under FDA QMSR, ISO 13485, CLIA/CAP, and other global regulations.

The role covers device history, document control, records management, supplier documentation, and internal/external audits. Shifts Sunday-Thursday or Tuesday-Saturday. Competitive salary in the Chicago area.

Qualifications

• High school diploma, 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.
• Good time management and communication skills.
• Self-driven and works well in a fast-moving, cross-functional team environment with minimal direction.
• Beginner ability to create processes, as well as suggest solutions to challenges.
• Beginner computer skills and software applications, including experience with Microsoft Office tools and/or Google Suite applications.
• Preferred Experience Previous experience in a clinical lab regulated by CAP/CLIA/NYS/FDA highly desirable

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

Skills

Attention to detail

Time management

Communication skills

Self-driven

Education

Bachelor's degree in Life Science or Engineering

Tools

Microsoft Office

Google Suite

Job description

Tempus AI, Inc. is seeking a Senior Quality Assurance Associate to document and track compliance for a clinical molecular laboratory. You will support QA activities under FDA QMSR, ISO 13485, CLIA/CAP, and other global regulations.

The role covers device history, document control, records management, supplier documentation, and internal/external audits. Shifts Sunday-Thursday or Tuesday-Saturday. Competitive salary in the Chicago area.