Senior Specialist, QA

4 weeks ago


Chicago, Illinois, United States Tempus AI Full time

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.

#LI-SH1


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.


  • Senior QA

    3 weeks ago


    Chicago, Illinois, United States Mitchell Martin Inc Full time

    Our Client, An American global markets company, is seeking a Senior QALocation: Chicago, ILPosition Type: Contract Job Summary:The QA Analyst is the subject matter expert (SME) within the project team. The QA must have good written and verbal communication skills; and be able to interface efficiently with all support groups, other QA groups, and development...


  • Chicago, Illinois, United States Duck Creek Technologies Full time

    Helping careers take flight. Reshaping an industry. Enable your career to be Made on Duck Creek. WHO WE ARE: Duck Creek Technologies is the intelligent solutions provider defining the future of the property and casualty (P&C) and general insurance industry. We are the platform upon which modern insurance systems are built, enabling the industry to capitalize...


  • Chicago, Illinois, United States UL Solutions Full time

    JOB DESCRIPTIONReporting to the Senior Manager, Product Marketing, the Senior Product Specialist-EHS leverages insights and competitive intelligence to develop and understand target buyers and markets. Executes go-to-market strategies including crafting messaging that attracts and converts prospects and leads, creating sales materials to facilitate positive...


  • Chicago, Illinois, United States Finn Partners Full time

    Finn Partners is looking for a Senior Insights Specialist to join their marketing team. The Senior Insights Specialist plays a crucial role in supporting the acquisition of new clients. They specialize in collecting and analyzing market intelligence, competitive research, media and industry trend data, and using these various sources of information to...


  • Chicago, Illinois, United States Allied Benefit Systems, LLC Full time

    SENIOR ELIGIBILITY SPECIALISTPOSITION SUMMARYThis position is responsible for setup and day to day operations of Allied's eligibility services technology platforms. These technology platforms include the following: Allied's eligibility system of record, client web-based eligibility maintenance portal, and X12-834 electronic data interchange (EDI). The...


  • Chicago, Illinois, United States Senior Lifestyle Full time

    Job DescriptionIn situations of NHA vacancy, serve as onsite executive for all operations, acting as contact for all staff, residents, prospects, community organizations, government agencies, and the public.Provide added support as needed to incumbent nursing home administrators, including but not limited to onboarding, training, leadership, and management...

  • Senior Specialist

    2 weeks ago


    Chicago, Illinois, United States United Airlines Full time

    This Chicago-based position will require, on average, three days per week in our downtown office.There's never been a more exciting time to join United Airlines. We're on a path toward becoming the best airline in the history of aviation. Our shared purpose – Connecting People, Uniting the World – is about more than getting people from one place to...

  • Senior Specialist

    4 weeks ago


    Chicago, Illinois, United States United Airlines Full time

    This Chicago-based position will require, on average, three days per week in our downtown office.There's never been a more exciting time to join United Airlines. We're on a path toward becoming the best airline in the history of aviation. Our shared purpose – Connecting People, Uniting the World – is about more than getting people from one place to...

  • Reporting Specialist

    4 weeks ago


    Chicago, Illinois, United States Orion Group Full time

    $27 - $30 per hour with option for medical benefits6 month initial contractHybrid schedule after training - standard first shift business hoursLocation: North Chicago, ILOrion Group and our client a market leading pharmaceutical company, have an exciting contract opportunity for a Reporting Specialist in North ChicagoWe are seeking candidates with Knowledge...

  • Senior Specialist

    1 month ago


    Chicago, Illinois, United States United Airlines Full time

    At United, we offer more than jobs, we build careers. Our HR team is passionate about growing our diverse, inclusive, and equitable workplace where everyone can thrive. We empower our team members to pursue unique career paths, promote a culture where all employees feel included and empowered to a make a measurable difference in our success, and value the...


  • Chicago, Illinois, United States Johnson & Johnson Full time

    Janssen Biotech, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for an Immunology Sales Specialist to support the South Chicago, IL territory. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where...


  • Chicago, Illinois, United States T.Y. Lin International Full time

    TYLin is a globally recognized, full-service infrastructure consulting firm committed to providing innovative, cost-effective, constructible designs for the global infrastructure market. With over 3,000 employees throughout the Americas, Asia, and Europe, the firm provides support on projects of varying size and complexity. Together, we enhance conventional...

  • Billing Specialist

    13 hours ago


    Chicago, Illinois, United States Blue Cross Blue Shield Association Full time

    Job Description Summary Specialist are committed to ensuring the accuracy of customer billing and processing vendor invoice payments. In addition, deliver exceptional customer service to both external and internal partners. The Specialist must also maintain the established internal control environment and assists in implementing corrections where...

  • Senior Analyst

    1 month ago


    Chicago, Illinois, United States United Airlines Full time

    Connecting People. Uniting the World. There's never been a more exciting time to join United Airlines As a global company that operates in hundreds of locations around the world — with millions of customers and tens of thousands of employees — we have a unique responsibility to uplift and provide opportunities in the places where we work, live and fly. ...


  • Chicago, Illinois, United States WARNERMEDIA Full time

    Every great story has a new beginning, and yours starts here.Welcome to Warner Bros. Discovery... the stuff dreams are made of.Who We Are... When we say, "the stuff dreams are made of," we're not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD's vast portfolio of iconic content and beloved...


  • Chicago, Illinois, United States Adtalem Global Education Full time

    Company DescriptionAbout Adtalem Global EducationAdtalem Global Education is a national leader in post-secondary education and leading provider of professional talent to the healthcare industry. Adtalem educates and empowers students with the knowledge and skills to become leaders in their communities and make a lasting impact on public health, well-being...


  • Chicago, Illinois, United States Adtalem Full time

    Company DescriptionAbout Adtalem Global EducationAdtalem Global Education is a national leader in post-secondary education and leading provider of professional talent to the healthcare industry. Adtalem educates and empowers students with the knowledge and skills to become leaders in their communities and make a lasting impact on public health, well-being...


  • Chicago, Illinois, United States NinjaHoldings Full time

    NinjaHoldings was founded in 2017 by a team seeking to revolutionize the way everyday Americans interact with financial services. Through our CreditNinja and NinjaCard brands, we empower people overlooked by traditional financial institutions to take control of their finances via a full suite of digital banking and lending products, providing incentives and...

  • Senior Analyst

    3 weeks ago


    Chicago, Illinois, United States Adtalem Global Education Full time

    Company DescriptionAbout Adtalem Global EducationAdtalem Global Education is a national leader in post-secondary education and leading provider of professional talent to the healthcare industry. Adtalem educates and empowers students with the knowledge and skills to become leaders in their communities and make a lasting impact on public health, well-being...


  • Chicago, Illinois, United States Exelon Full time

    DescriptionWe're powering a cleaner, brighter future.Exelon is leading the energy transformation, and we're calling all problem solvers, innovators, community builders and change makers. Work with us to deliver solutions that make our diverse cities and communities stronger, healthier and more resilient.We're powered by purpose-driven people like you who...