Senior Specialist, QA

1 month 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.



  • Chicago, Illinois, United States Motion Recruitment Full time

    Company Overview: A dynamic software organization is seeking a skilled QA Automation Engineer to enhance their automated testing capabilities. This role involves developing and executing test scripts from the ground up to ensure the highest quality standards across various software solutions.Role Responsibilities:As a QA Automation Engineer, you will be...


  • Chicago, Illinois, United States Diverse Lynx Full time

    Job Summary:We are seeking a highly skilled QA Automation Specialist to join our team at Diverse Lynx LLC. As a key member of our team, you will be responsible for designing, developing, and implementing automated testing solutions to ensure the highest quality of our products.Key Responsibilities:Design and develop automated testing frameworks using Java,...


  • Chicago, Illinois, United States Tempus Full time

    Job Summary:Tempus is seeking a highly skilled Senior Quality Assurance Specialist to support quality activities related to incidents and issues, including deviations, nonconformances (NC), and corrective and preventive actions (CAPA) in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other applicable global regulations.Key...


  • Chicago, Illinois, United States LHH Recruitment Solutions Full time

    Job OverviewPosition: Senior Accounting SpecialistLHH Recruitment Solutions is a prominent HR Solutions provider currently looking for a Senior Accounting Specialist. This role involves overseeing essential accounting functions to ensure the financial integrity of the organization.The Senior Accounting Specialist will be tasked with executing daily financial...


  • Chicago, Illinois, United States Sunrise Senior Living Full time

    About the RoleSunrise Senior Living is seeking a highly skilled Maintenance Specialist to join our team. As a key member of our facilities management team, you will be responsible for ensuring the day-to-day operations of our community's facilities and grounds are safe, clean, and comfortable for our residents.ResponsibilitiesMaintain a safe and clean...


  • Chicago, Illinois, United States PCG INTERNATIONAL INC Full time

    Job OverviewPCG International Inc. is a forward-thinking and technology-focused organization dedicated to enhancing the effectiveness of health, education, and human services sectors. We are currently seeking a Senior Salesforce HR Support Specialist to provide expert technical assistance and support for Salesforce-related functionalities within our Human...


  • Chicago, Illinois, United States Amada Senior Care Full time

    Amada Senior Care: Providing Exceptional Senior Home Care ServicesWe are a leading provider of senior home care services, dedicated to enriching the lives of seniors and their families. Our team of compassionate caregivers understands the importance of personalized care and strives to make a positive impact on every client's life.Our Caregivers: The Heart of...


  • Chicago, Illinois, United States Meet Full time

    Exciting Opportunity for Senior Medical Writing SpecialistWe are collaborating with a prominent pharmaceutical organization seeking a committed Senior Medical Writing Specialist to become part of their innovative immunology division. This remote role provides an opportunity to significantly impact the creation of clinical documentation, emphasizing...


  • Chicago, Illinois, United States University of Illinois Chicago Full time

    Senior Research Specialist - Research NavigationSenior Research Specialist - Research NavigationHiring Department: Elizabeth HawesLocation: Chicago, IL USARequisition ID: Posting Close Date: September 10, 2024About the University of Illinois ChicagoUIC is among the nation's preeminent urban public research universities, a Carnegie RU/VH research institution,...


  • Chicago, Illinois, United States Komatsu Full time

    Position: Senior Infrastructure SpecialistCompany Overview:Komatsu is a vital collaborator in the construction, mining, forestry, forklift, and industrial machinery sectors, delivering exceptional value to clients through innovative solutions. Our extensive range of products, supported by cutting-edge IoT technologies, regional distribution networks, and a...


  • Chicago, Illinois, United States Metropolitan Water Reclamation District of Greater Chicago Full time

    Job Title: Senior Inventory Control SpecialistOverviewThe Senior Inventory Control Specialist is tasked with managing and supervising inventory and cataloguing functions, ensuring that inventory levels are optimized for operational efficiency.Key ResponsibilitiesConducting regular cycle counts and addressing discrepancies in physical inventoriesAnalyzing...


  • Chicago, Illinois, United States Senior Lifestyle Full time

    Job SummaryWe are seeking a skilled and compassionate Certified Nursing Assistant to join our team at Senior Lifestyle. As a key member of our care team, you will play a vital role in providing exceptional care and support to our residents.Key ResponsibilitiesTaking and Recording Vital Signs: Accurately measure and record residents' vital signs, including...


  • Chicago, Illinois, United States Actalent Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Quality Control: Perform wet chemistry lab analysis on raw materials, in-process, and finished products, including pH,...


  • Chicago, Illinois, United States Compass Group, North America Full time

    Company Overview:Crothall Healthcare, a division of Compass Group, North America, is a leader in providing specialized support services exclusively to the healthcare sector. With a commitment to high-quality service, we empower our team members to enhance healthcare experiences across the nation.Position Summary:We are currently seeking a full-time Senior...


  • Chicago, Illinois, United States AbbVie Full time

    About the Role:The Digital Lab Senior Email Specialist at AbbVie is responsible for the day-to-day management, oversight, and optimization of a team of digital communications specialists in the CRM Digital Lab, creating non-personal promotion and field communication campaigns.Key Responsibilities:Oversee the development and implementation of digital...


  • Chicago, Illinois, United States DLA Piper Full time

    DLA Piper embodies a culture that is bold, exceptional, collaborative, and supportive. Our workforce is the backbone, heart, and soul of our firm. No matter where you are in your professional journey, DLA Piper offers a platform for engaging in meaningful work and advancing your career. Position Overview The Senior Accounting Specialist plays a vital role...


  • Chicago, Illinois, United States UL Solutions Full time

    RESPONSIBILITIESThe Senior Regulatory Specialist responsible for Canadian legislation identifies, collects, and interprets science-based reports, data and regulations in order to prepare documents for government agencies, curate lists and/or develop Environment, Health, Safety, and Transportation (EHS&T) information for the control and use of chemicals in...


  • Chicago, Illinois, United States DLA Piper Full time

    DLA Piper embodies a culture that is bold, exceptional, collaborative, and supportive. Our workforce is the backbone, heart, and soul of our firm. No matter where you are in your professional journey, DLA Piper is a place where you can engage in meaningful work and advance your career. Together, we can achieve remarkable outcomes. Position Overview The...


  • Chicago, Illinois, United States Ad Atlantic Full time

    Senior Financial Reporting SpecialistAd Atlantic is a prominent player in the proprietary trading sector, seeking to appoint a Senior Financial Reporting Specialist to enhance our dedicated team of three professionals. This role is pivotal in managing intricate accounting challenges and adapting to evolving regulatory requirements, ensuring adherence to GAAP...


  • Chicago, Illinois, United States Burns & McDonnell Full time

    Become a part of our innovative team as a Senior Civil Engineering SpecialistAre you eager to engage in impactful water resource projects? Burns & McDonnell is on the lookout for a talented Senior Civil Engineering Specialist to enhance our capabilities in the water sector. If you possess a solid background in civil engineering and a commitment to executing...