Senior Quality Assurance Specialist/ Quality Assurance Specialist

Tempus AI • Chicago, IL

19h • $55,000 - $70,000 • Onsite

About The Position

Tempus is seeking a Senior Quality Assurance Specialist or Quality Assurance Specialist to support quality activities in its precision medicine and healthcare operations. The role helps maintain quality documentation and processes in compliance with applicable CLIA, CAP, NYS-DOH, and FDA requirements. This is an onsite position.

The specialist compiles and approves Device History Records, performs incoming material acceptance activities, maintains controlled documentation and quality records, supports audits, and helps identify and resolve quality issues. The role works with management and testing personnel to coordinate quality tasks and maintain training and personnel records in electronic quality management systems.

Requirements

• High school diploma required.
• 2–4 years of experience with clerical or 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 smoothly to new processes.
• Excellent time management and communication skills.
• Self-driven and able to work well in a fast-moving, cross-functional team environment with minimal direction.
• Ability to create processes and workflows and define and create solutions to challenges.
• Intermediate computer skills and software application skills, including experience with Microsoft Office tools and/or Google Suite applications.

Nice To Haves

• Bachelor’s degree in Science or Engineering preferred.
• Previous experience in a clinical laboratory regulated by CAP, CLIA, NYS, or FDA is highly desirable.

Responsibilities

• Compile and approve the Device History Record.
• Complete incoming material acceptance activities.
• Read, understand, and update SOPs in the document control system, including creating, revising, and reviewing internal SOPs and other quality documentation.
• File quality documentation systematically and maintain documentation to satisfy CLIA, CAP, NYS-DOH, and FDA requirements.
• Provide metrics to identify trends, conduct root cause analysis, and develop corrective actions to prevent recurrence of quality issues.
• Report significant deviations and system deficiencies to management as appropriate.
• Interact with management and testing personnel to coordinate quality tasks.
• Pull records and reports as requested during internal and external audits.
• Help facilitate and implement corrective and preventative actions.
• Track and maintain quality records, including batch records, checklists, competency assessments, quality and equipment binders, and continuing education documentation.
• Complete and maintain onboarding, offboarding, and transfer duties within electronic quality management systems.
• Maintain the training matrix and training document master list.
• Assist with document control workflow as needed.

Benefits

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

What This Job Offers

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