Quality Assurance Associate

Tempus AI • Chicago, IL

8h

About The Position

The Quality Assurance Associate is responsible for documenting and tracking compliance for a clinical molecular laboratory. The role supports quality assurance activities in accordance with FDA QMSR, ISO 13485, other applicable global regulations, and CLIA/CAP requirements for clinical laboratories. Responsibilities include records management, acceptance activities, and production and process control. The position works a Sunday-to-Thursday or Tuesday-to-Saturday shift.

The associate compiles Device History Records, maintains organized quality records, supports document control and supplier compliance activities, and helps prepare for internal and external audits. The role also reports significant deviations and system deficiencies to management and assists with corrective and preventive actions.

Requirements

• High school diploma.
• 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 smoothly to new processes.
• Good time-management and communication skills.
• Self-driven and able to work well in a fast-moving, cross-functional team environment with minimal direction.
• Beginner ability to create processes and suggest solutions to challenges.
• Beginner computer skills and experience with software applications, including Microsoft Office tools and/or Google Suite applications.
• 0–2 years of experience in industry, quality, or clerical/documentation handling.

Nice To Haves

• Bachelor’s degree in Life Science or Engineering.
• Previous experience in a clinical lab regulated by CAP, CLIA, NYS, or FDA.

Responsibilities

• Compile Device History Records.
• Read and understand SOPs within the document control system.
• File quality records in a systematic, organized manner.
• Maintain documentation to satisfy CLIA, CAP, NYS-DOH, and FDA requirements.
• Track and maintain 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 requested during internal and external audits.
• Help facilitate and implement corrective and preventive actions.
• Assist with document control workflow as needed.
• Work proactively with suppliers to ensure documentation on file is up to date.
• Send and review supplier questionnaires.
• Maintain supplier certificates.
• Review and escalate customer and supplier notifications.
• Review documents received and escalate concerns for further review.

Benefits

• Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED