Specialist, QA

3 weeks ago

Chicago, 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's 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 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.
  • 1+ year 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.

  • QA Specialist Ii/iii

    6 days ago

    Chicago, United States Locks Global Staffing LLC Full time

    As a **Quality Assurance Specialist II/III **you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing. ** Please note this position’s...

  • Specialist, QA

    1 month ago

    Chicago, United States Tempus 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's proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...

  • Specialist, QA

    3 weeks ago

    Chicago, United States Tempus 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's proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...

  • QA Specialist II

    5 days ago

    North Chicago, Illinois, United States Tellus Solutions Full time

    Tellus Solutions is in partnership with a committed biopharmaceutical company in North Chicago focused on providing innovative therapies. Your technical expertise as a QA Specialist II in the area of Trackwise, Change Management which will impact the quality and duration of life. Job Description: Responsibilities: All change management, limited decision...

  • Senior Specialist, QA

    7 days ago

    Chicago, United States Tempus Full time

    Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impactclinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem ofreal-world evidence to deliver real-time, actionable insights to physicians, providing...

  • Senior Specialist, QA

    1 month ago

    Chicago, United States Tempus 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...

  • Senior Specialist, QA

    1 month ago

    Chicago, 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...

  • Senior Specialist, QA

    5 days ago

    Chicago, United States Tempus 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...

  • Senior Specialist, QA

    3 weeks ago

    Chicago, United States Tempus 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...

  • QA Auditor, GLP

    4 weeks ago

    Chicago, United States Frontage Laboratories Full time

    Job DescriptionJob DescriptionQA Specialist/Auditor, GLPTitle: QA Specialist/Auditor, GLPLocation: Chicago, IL (onsite)Reports to: Senior Director of Quality AssuranceFull-timeFrontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US,...

  • QA/case Manager

    3 weeks ago

    Chicago, United States Heroes Home Health Full time

    We are looking for a motivated QA specialist to to work with a team of skilled professionals. Your responsibilities will include, but are not limited to the following: Responsible for the timely completion and accuracy of all clinical documentation including OASIS, Plan of Care, Visit Notes, etc. - Analyze, edit OASIS visit documentation and corresponding...

  • QA Compliance Specialist(Trackwise/sap/change

    6 days ago

    North Chicago, United States Infobahn Softworld Inc Full time

    **Quality Assurance (QA) Compliance Specialist II** **hybrid Role 3 days in office and 2 days work from home** **Length of Contract: 6 Months, with a possibility of extension** **Job Title**:Specialist, Quality Systems, Compendia Affairs **Purpose**: **Responsibilities**: - Review of proposed and official compendia updates - Create records to document...

  • Senior Specialist, QA IT Systems

    2 weeks ago

    North Chicago, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...

  • Wet Chemistry, QA Technician

    4 days ago

    Chicago, United States Managed Care Staffers Full time

    Job DescriptionJob DescriptionWet Chemistry, QA Technician Chicago, IL (Midway)Our client manufactures and packages consumer goods, is seeking a wet chemistry, Quality Assurance Technician. This is a full-time position that is located in the Midway neighborhood.  Must be okay with occasionally working overtime.Days & Hours Worked: M-TH, 5am-3:30pmBasic...

  • Sr. Specialist Software Development

    4 days ago

    Chicago, Illinois, United States The Charles Schwab Corporation Full time

    At Schwab, you're empowered to make an impact on your career. Here, innovative thought meets creative problem solving, helping us "challenge the status quo" and transform the finance industry together. Develop and execute software tests to identify s Software, Engineer, Development, Specialist, Automation, Technology, QA

  • Senior Salesforce CRM Specialist

    7 days ago

    Chicago, United States GrowthAssistant Full time

    GrowthAssistant is seeking a Senior Salesforce CRM Specialist to join our team. The specialist will spearhead the creation and implementation of CRM strategies to ensure effective merchant activation, onboarding, and education. Responsibilities include managing multi-channel campaigns, conducting QA tests, evaluating performance metrics, and collaborating...

  • Salesforce Email Marketing Specialist

    6 days ago

    Chicago, United States GrowthAssistant Full time

    GrowthAssistant is currently looking for a Salesforce Email Marketing Specialist to join our team. The role will lead the development and execution of CRM strategies, ensuring effective activation, onboarding, and education of merchants. They will manage cross-channel campaigns, perform QA testing, analyze performance, and collaborate with cross-functional...

  • QA/Expeditor - Chicago T1 B&B-HMS Host

    1 month ago

    Chicago, United States Chili's Grill & Bar Full time

    QA/Expeditor - Chicago T1 B&B-HMS Host PO Box 66048 Bld 6 O'Hare Field Term 1 Chicago, IL 60666 This location is operated by an independent franchise owner. Benefits may vary by location. When applying, please note that current job availability is found by clicking the link to the franchise specific hiring website. Role Overview Our Quality Assurance...

  • QA/Expeditor - Chicago T1 B&B-HMS Host

    3 weeks ago

    Chicago, United States Chili's Grill & Bar Full time

    QA/Expeditor - Chicago T1 B&B-HMS Host PO Box 66048 Bld 6 O'Hare Field Term 1 Chicago, IL 60666 This location is operated by an independent franchise owner. Benefits may vary by location. When applying, please note that current job availability is found by clicking the link to the franchise specific hiring website. Role Overview Our Quality Assurance...

  • QA/Expeditor - Chicago T1 B&B-HMS Host

    5 days ago

    Chicago, United States Chili's Grill & Bar Full time

    QA/Expeditor - Chicago T1 B&B-HMS Host PO Box 66048 Bld 6 O'Hare Field Term 1 Chicago, IL 60666 This location is operated by an independent franchise owner. Benefits may vary by location. When applying, please note that current job availability is found by clicking the link to the franchise specific hiring website. Role Overview Our Quality Assurance...