Quality Assurance Associate

Tempus; United States; On-site; USD 40,000 - 67,000; Full time

Job summary

Tempus is seeking a Senior Quality Assurance Associate or Specialist to document and track compliance for a clinical molecular laboratory. This role supports quality assurance activities in line with FDA QMSR, ISO 13485, and other global regulations, including CLIA/CAP requirements.

The position involves maintaining records, ensuring systematic documentation, and assisting with corrective/preventive actions.

Qualifications

• High school diploma or 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.

Responsibilities

• Compile the Device History Record.
• Read and understand SOPs within the document control system.
• File quality records in a systematically organized manner.
• Maintain documentation to satisfy CLIA/CAP/NYS-DOH/FDA requirements.
• Assist in tracking and maintenance of quality records, including batch records, checklists, and quality/equipment binders.
• Report significant deviations and system deficiencies to management under guidance.
• Pull records and reports during audits.
• Help facilitate and implement corrective and preventive actions.

Skills

Attention to detail

Time management

Documentation handling

Education

High school diploma

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.
• Readand understandSOPswithinthedocumentcontrolsystem.
• Filequalityrecordsinasystematicorganizedmanner.
• MaintaindocumentationinordertosatisfyCLIA/CAP/NYS-DOH/FDArequirements.
• Aidintrackingandmaintenanceofqualityrecords,includingbatchrecords,checklists,andqualityandequipmentbinders.
• Reportsignificantdeviationsandsystemdeficienciestomanagement,underguidanceandasappropriate.
• Pullrecordsandreportsasrequestedduringinternalandexternalaudits.
• Helpfacilitateandimplementcorrectiveandpreventiveactions.

Other Responsibilities

• Assistindocumentcontrolworkflow,asneeded.
• ManageSupplierDocumentationandCompliance,asneeded: Proactivelyworkwithsupplierstoensuredocumentationonfileisuptodate
• SendandReviewSupplierQuestionnaires
• Maintainsuppliercertificates
• Reviewandescalat**e** customer and supplier notifications
• Reviewdocumentsreceivedandescalateanyconcernsforfurtherreview

Minimum Qualifications/Experience

• High school diploma,Bachelor's Degreein 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