Clinical Genomics QA Associate | Lab Compliance

Tempus; Chicago (IL); On-site; USD 27,000 - 45,000; Full time

Benefits offered by this job

Benefits package

Job summary

Tempus, a Chicago-based company advancing precision medicine, seeks a Senior Quality Assurance Associate or QA Specialist to document and track compliance for a clinical molecular laboratory under FDA QMSR, ISO 13485, CLIA/CAP. Shifts: Sun–Thu or Tue–Sat.

The role supports QMS activities, maintains records, and works with suppliers to ensure up-to-date documentation; corporate benefits are provided.

Qualifications

• Bachelor's Degree in Life Science or Engineering preferred.
• 0-2 years of experience in 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.

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

High attention to detail

Highly organized

Time management

Documentation skills

Communication skills

Education

Bachelor's Degree in Life Science or Engineering

High school diploma

Tools

Microsoft Office

Google Workspace

Job description

Tempus, a Chicago-based company advancing precision medicine, seeks a Senior Quality Assurance Associate or QA Specialist to document and track compliance for a clinical molecular laboratory under FDA QMSR, ISO 13485, CLIA/CAP. Shifts: Sun–Thu or Tue–Sat.

The role supports QMS activities, maintains records, and works with suppliers to ensure up-to-date documentation; corporate benefits are provided.