Senior Quality Assurance Specialist/ Quality Assurance Specialist

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.

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 Quality Assurance Specialist or Senior 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 and approval of the Device History Record. 

• Complete incoming material acceptance activities.

• Read, understand, and update SOPs within the document control system, including creation/revision/review of internal SOPs and other quality documentation.

• File quality documentation in a systematic organized manner.

• Maintain documentation in order to satisfy CLIA/CAP/NYS-DOH/FDA requirements.

• Provide metrics to identify trends and conduct root cause analysis, and develop corrective actions to prevent the recurrence of quality issues

• Report significant deviations and system deficiencies to management, as appropriate.

• Interact with management and testing personnel to coordinate Quality tasks.

• Pull records and reports as requested during internal and external audits.

• Help facilitate and implement corrective and preventative actions.

Other Responsibilities:

• Aid in tracking and maintenance of quality records, including batch records, checklists, and quality and equipment binders.

• 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 review

Qualifications:

• Bachelor’s Degree in Life Science or Engineering

• 2-4 years of experience in industry or Quality

• 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

• Excellent time management and communication skills

• Self-driven and works well in a fast-moving, cross-functional team environment with minimal direction

• Ability to create processes and workflows, as well as define and create solutions to challenges

• Intermediate 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: $55,000-$100,000
 

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.