Full-Time

Senior Specialist

Tempus

Tempus

1,001-5,000 employees

AI-driven precision medicine through clinical and molecular data analysis

Data & Analytics
AI & Machine Learning

Senior

Chicago, IL, USA

Required Skills
Communications
Quality Assurance (QA)
Requirements
  • Bachelor's Degree in Engineering or Science field.
  • 3+ of QA experience in a clinical laboratory/medical device/Diagnostic company, working on deviations, Nonconformances and CAPA processes.
  • Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, and other applicable quality and regulatory standards).
  • QA experience in a clinical molecular testing laboratory (LDTs) is required.
  • Strong communication (written and verbal), influencing, negotiating and collaboration skills.
  • Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
  • Ability to manage multiple tasks with limited supervision.
  • Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.
  • Ability and willingness to work independently and take initiative to ensure timely action on issues.
Responsibilities
  • Responsible for processing and managing issues/incidents that include deviations, NCs, and CAPAs, as well as ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
  • Participate in process improvements to the issue/incident reporting framework by helping identify areas for improvement, simplification, and standardization, ensuring that the various systems are streamlined and aligned.
  • Collaborate with Regulatory on appropriate health authority reporting, as necessary.
  • Assist in NC/CAPA activities, including investigations, root cause analysis, effectiveness verification, and closure by establishing cross-functional relationships and collaborations with functional owners.
  • Drive ownership of issues/incidents to lead to final resolution and closure by providing training and guidance to owners.
  • Responsible for assisting in activities to ensure departmental goals for deviations, NC and CAPA processes are achieved.
  • Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues
  • Participate if needed as a NC and CAPA subject matter expert during internal and external audits.
  • Lead and/or support other duties as assigned.

Tempus Labs, Inc. is a leader in precision medicine, leveraging artificial intelligence to analyze vast clinical and molecular data, enabling physicians to deliver personalized, data-driven care. The company's advanced machine learning platform and unique solution sets facilitate the discovery, development, and delivery of optimized therapeutic options for patients. With a focus on extensive molecular profiling, Tempus has developed a robust pan-cancer tumor organoid platform and validated a liquid biopsy assay, demonstrating their commitment to transforming personalized patient care and their position at the forefront of the healthcare industry.

Company Stage

Series G

Total Funding

$1.3B

Headquarters

Chicago, Illinois

Founded

2015

Growth & Insights
Headcount

6 month growth

5%

1 year growth

32%

2 year growth

52%
INACTIVE