Quality Assurance Associate

Tempus AI; Chicago (IL); On-site; USD 41,000 - 67,000; Full time

Benefits offered by this job

Benefits package

Job summary

Tempus AI is seeking a Senior Quality Assurance Associate or Quality Assurance Specialist to document and track compliance for a clinical molecular laboratory. Responsibilities include maintaining records per FDA QMSR, ISO 13485, CLIA/CAP, and other global regulations, across document control, batch records, and audits.

The role supports QMS activities and requires a high level of organization, attention to detail, and ability to work with cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor’s degree in Life Science or Engineering; 0–2 years in QA or documentation handling.
• Highly organized with superb attention to detail.
• Able to learn quickly and adapt to new processes.
• Good time management and communication skills.
• Self-driven in a fast-moving, cross-functional team environment.

Responsibilities

• Compile the Device History Record.
• Read and understand SOPs in the document control system.
• File quality records systematically.
• Maintain documentation to meet CLIA/CAP/NYS/FDA requirements.
• Assist in audits and prepare records for internal/external reviews.
• Support corrective and preventive actions.

Skills

Quality Assurance

Documentation

Attention to detail

Time management

Cross-functional teamwork

Education

Bachelor’s Degree in Life Science or Engineering

Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus’ proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Job Description

Passionate about making a difference in the world of cancer genomics? With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don’t have the infrastructure or expertise to make sense of this data. We’re on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings.

We are looking for a Senior Quality Assurance Associate or Quality Assurance Specialist who will be responsible for documenting and tracking compliance for a clinical molecular laboratory. This individual will play an integral role in supporting quality assurance activities in accordance with FDA QMSR (Quality Management System Regulation), ISO 13485, and other applicable global regulations, including but not limited to records management, acceptance activities, production and process control. This individual also supports the QMS activities that comply with CLIA/CAP requirements for the clinical laboratories.

The shift for this position is Sunday to Thursday OR Tuesday to Saturday.

Key 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.

Other Responsibilities:

• Assist in document control workflow, as needed.
• Manage Supplier Documentation and Compliance, as needed:

Minimum Qualifications/Experience

• 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

Illinois Pay Range: $19.47 - $32.45

The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.