Quality Assurance Associate — Clinical Lab Compliance

Tempus; 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 in Chicago, IL is seeking a Senior Quality Assurance Associate or Quality Assurance Associate to document and track compliance for a clinical molecular laboratory. The role supports QA activities in line with FDA QMSR, ISO 13485, and CLIA/CAP requirements.

The position involves compiling Device History Records, maintaining quality records, and coordinating audits. Shifts are Sunday-Thursday or Tuesday-Saturday, with a strong emphasis on precision and cross-functional collaboration.

Qualifications

• High school diploma not required but preferred? Wait see text: Minimum Qualifications/Experience includes 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

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 regulatory requirements (CLIA/CAP/NYS-FDA).
• Track and maintain quality records, including batch records, checklists, and equipment binders.
• Report significant deviations and system deficiencies to management.
• Pull records and reports during audits.
• Help facilitate and implement corrective and preventative actions.
• Assist in document control workflow as needed.
• Manage supplier documentation and compliance: update records with supplier certifications and questionnaires.

Skills

Attention to detail

Time management

Documentation handling

Education

Bachelor's Degree in Life Science or Engineering

Job description

Tempus in Chicago, IL is seeking a Senior Quality Assurance Associate or Quality Assurance Associate to document and track compliance for a clinical molecular laboratory. The role supports QA activities in line with FDA QMSR, ISO 13485, and CLIA/CAP requirements.

The position involves compiling Device History Records, maintaining quality records, and coordinating audits. Shifts are Sunday-Thursday or Tuesday-Saturday, with a strong emphasis on precision and cross-functional collaboration.