Senior Specialist, QA

| Chicago, IL, USA | Hybrid
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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 Assurance Specialist plays an integral role in supporting quality activities related to incidents and issues, including deviation, nonconformances (NC) and corrective and preventive actions (CAPA) in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other applicable global regulations. This individual also supports the QMS activities that comply with CLIA/CAP requirements for the clinical laboratories.

Responsibilities include the following. Other duties may be assigned.

  • 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.

Required Education and Experience:

  • 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.
  • Working knowledge of the deviations, NC and CAPA processes.
  • 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.
  • 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.

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Technology we use

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Our Chicago office is located in downtown River North. Right on the river and close to neighborhoods like Fulton Market, Central Business District, Lincoln Park, and Streeterville, it's a lively area with convenient transportation access and is home to many bars, restaurants, and coffee shops.

An Insider's view of Tempus AI

What’s the vibe like in the office?

The casual setting here in the Chicago office makes everyone less intimidating and more approachable. It's nice to be in an environment where our day-to-day work actually makes a difference, I feel valued. Tempus is also great at welcoming everyone with different backgrounds.


Clinical Lab Associate

How do you collaborate with other teams in the company?

I collaborate with various hiring teams on a daily basis. Through weekly meetings, strategic planning, events, and messaging, hiring teams and I have built a collaborative hiring process and have become trusted partners to bring top talent to Tempus. We rely on honest communication, shared goals, and the right tools to set us up for success!



How does the company support your career growth?

I am always looking for the next opportunity to grow my career, and Tempus has a wealth of opportunities in many departments. Through emerging leaders programs and ongoing conversations with my managers, Tempus has always been supportive in guiding me to find work that is fun, interesting, and maximizes my potential.


Senior Operations Manager

What are some things you learned at the company?

One of the things that molded my growth was seeing how much thought goes into the decisions, and how much leadership seeks feedback from the people around them, to help understand the impact of decision-making. Just being a sponge in the room is inspiring. I adapted the styles of many leaders here and use that to create my own leadership style.


Laboratory Operations Manager

What are Tempus AI Perks + Benefits

Tempus AI Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Employee Assistance Program (EAP)
Pet Insurance
Company Cafeteria with Breakfast, Lunch & Grab & Go Options
Stocked Kitchen with Snacks
On-Site Barista
Discounted Gym Membership
Discounted Divvy Membership
Diversity & Inclusion Initiatives
Team & Company Outings

Volunteer in local community
Open door policy
OKR operational model
Team based strategic planning
Pair programming
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
Flexible work schedule
Remote work program
Highly diverse management team
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance + Wellness
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Pet insurance
Wellness programs
Mental health benefits
Financial & Retirement
Company equity
Charitable contribution matching
Child Care & Parental Leave
Generous parental leave
Family medical leave
Vacation + Time Off
Unlimited vacation policy
Generous PTO
All staff in Tempus’ laboratories are subject to Tempus’ separate laboratory PTO policies.
Paid volunteer time
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Office Perks
Commuter benefits
Company-sponsored outings
Free snacks and drinks
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Meditation space
Mother's room
Onsite gym
Professional Development
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Continuing education available during work hours

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