Senior Quality Assurance Specialist

Tempus AI•Chicago, IL

About The Position

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.

Requirements

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

Nice To Haves

Previous experience in a clinical lab regulated by CAP/CLIA/NYS/FDA highly desirable

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.
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.