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Senior Quality Assurance Specialist



Quality Assurance
Chicago, IL, USA
Posted on Wednesday, November 15, 2023

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.

The Senior Quality Systems Specialist plays an integral role in supporting and
providing quality oversight for activities related to CAP/CLIA/NYS requirements for
Tempus Clinical Laboratory. This role will report to the Senior QA Manager.

Responsibilities include the following. Other duties may be assigned.
1. Collaborate cross-functionally to support the maintenance and improvement of Tempus’ Quality Management System (QMS) in accordance with regulatory standards and requirements.

2. Lead, coordinate and support various QMS activities such as:

a. Maintenance of training plans and training records, including job
descriptions, CVs, and delegations
b. Non-conformances and deviations
c. Corrective and preventive actions (CAPAs)
d. Maintenance of quality metrics across all QMS functional areas and perform data analysis to identify opportunities for quality improvement
e. Customer complaints and issue management
f. Internal and external quality audit readiness
g. Proficiency testing and alternate performance assessments

3. Administering Tempus’ electronic quality management system (eQMS), supporting regulatory compliance such as Personnel Documentation, InspectionProof, Compliance/CE, and others as applicable.

4. Supports the Clinical Laboratory to ensure CAP/CLIA/NYS/FDA regulatory compliance in all aspects of laboratory operations.

5. Monitors and tracks pre-analytical, analytical, and post analytical performance and advises staff when performance standards are not met.

6. Authors and reviews policies and/or procedures..

7. Maintain CLIA certification, CAP accreditation and State licensure for the clinical laboratory as required.

8. Conduct laboratory walkthroughs and CAP self-inspections for the clinical laboratory.

9. Lead inspection readiness efforts and host inspections as needed.

10. Perform other job-related duties, as assigned.

Required Qualifications:
● Bachelor' s Degree and/or 3 to 6 years of experience in a clinical laboratory/medical device/Diagnostics company with a minimum of 3 years with direct experience in CAP/CLIA/NYSDOH clinical laboratory.
● Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy
● Strong interpersonal skills in the areas of written and verbal communication
● Self-motivated, organized, able to prioritize and organize time effectively
● Experience working cross functionally to perform root cause investigations and to implement effective corrective actions
● Previous experience in a clinical lab regulated by CAP/CLIA/NYSDOH is highly desirable. Experience in the FDA regulated industry - medical devices or IVDs is a plus.
● This will be an on-site 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.