Quality Assurance Associate

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

Quality Assurance Associate# Careers## Quality Assurance AssociateApply: Chicago: Full time: Posted Today: JR202601120**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 DescriptionPassionate 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 Associate** 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: + Proactively work 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 any concerns for further reviewMinimum 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 desirableChicago/National: $23.00-$26.00/hr 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.