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 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 criticalinformation about the right treatments for the right patients, at the right time.

The Senior Quality Assurance Specialist

plays an integral role in supporting quality activitiesrelated to incidents and issues, including deviation, nonconformances (NC) and corrective andpreventive actions (CAPA) in accordance with FDA QSR (Quality System Regulation), ISO13485, and other applicable global regulations. This individual also supports the QMS activitiesthat 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 byhelping identify areas for improvement, simplification, and standardization, ensuringthat 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 relationshipsand collaborations with functional owners.

Drive ownership of issues/incidents to lead to final resolution and closure byproviding 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 correctiveactions to prevent the recurrence of quality issues

Participate if needed as a NC and CAPA subject matter expert during internal andexternal 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 CFR820, 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 collaborationskills.

Ability to work through complex issues and differences in a creative, constructive, anddiplomatic manner.

Ability to manage multiple tasks with limited supervision.

Ability to demonstrate leadership in helping improve quality processes and createefficiencies for business needs.

Ability and willingness to work independently and take initiative to ensure timely actionon issues.

This will be an on-site position.

#LI-SH1

#J-18808-Ljbffr



  • 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 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...

  • Senior QA Manager

    2 weeks ago


    Chicago, United States Blackthorn LLC Full time

    Role: Senior QA Manager Compensation: Base Salary of $120,000 to $130,000 USD Description: We are seeking a seasoned QA Manager with experience in implementing and shaping the company’s QA processes and strategies to head our Quality Assurance department . The ideal candidate will own all QA functions, ensuring the highest standards of quality are met for...

  • Specialist, QA

    1 week 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...


  • Chicago, United States The LaSalle Group Full time

    Our client is one of the top law firms in the world, known for its excellence and commitment to providing legal services of the highest caliber. They are looking for a dynamic Senior Benefits Specialist to join their team! The Senior Benefits Specialist will be responsible for managing the employee benefits programs while also maintaining focus on health...


  • Chicago, United States LaSalle Network Full time

    Our client is one of the top law firms in the world, known for its excellence and commitment to providing legal services of the highest caliber. They are looking for a dynamic Senior Benefits Specialist to join their team! The Senior Benefits Specialist will be responsible for managing the employee benefits frograms while also maintaining focus on health and...


  • Chicago, United States LaSalle Network Full time

    Our client is one of the top law firms in the world, known for its excellence and commitment to providing legal services of the highest caliber. They are looking for a dynamic Senior Benefits Specialist to join their team! The Senior Benefits Specialist will be responsible for managing the employee benefits programs while also maintaining focus on health and...


  • Chicago, United States LaSalle Network Full time

    Our client is one of the top law firms in the world, known for its excellence and commitment to providing legal services of the highest caliber. They are looking for a dynamic Senior Benefits Specialist to join their team! The Senior Benefits Specialist will be responsible for managing the employee benefits programs while also maintaining focus on health and...


  • Chicago, United States LaSalle Network Full time

    Our client is one of the top law firms in the world, known for its excellence and commitment to providing legal services of the highest caliber. They are looking for a dynamic Senior Benefits Specialist to join their team! The Senior Benefits Specialist will be responsible for managing the employee benefits programs while also maintaining focus on health and...


  • Chicago, United States Sunrise Senior Living Full time

    Overview **_ "Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what’s right for the resident. For me, that’s a big breath of fresh air."_** - **_Sunrise Leader_** At Sunrise, our Maintenance Specialist is responsible for the day-to-day...


  • Chicago, 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...


  • Chicago, 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...


  • Chicago, United States Edxmarkets Full time

    EDX is seeking a full-time Senior QA Automation Engineer to join its Engineering Department, responsible for testing the next generation digital assets trading platform. In this position you will collaborate with stakeholders, get to know the ins and outs of the digital asset space, and get to contribute on building an entire marketplace from the ground up....


  • Chicago, United States Jaybird Senior Living Full time

    Job DescriptionJob DescriptionAbout the Company:There are jobs – and then there are careers.At Jaybird Senior Living, we offer team members the chance to do the kind of work that is meaningful and makes a difference every day. We are looking for people who live our mission of demonstrating exemplary red carpet service in all we do. The opportunity to grow,...

  • QA Analyst

    1 month ago


    Chicago, United States Global Payments Full time

    Every day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services. Our worldwide team helps over 3 million companies, more than 1,300 financial institutions and over 600 million cardholders grow with confidence and achieve amazing results....


  • Chicago, United States OpenGov Full time

    Job Summary:The Senior Content Marketing Specialist will work closely with colleagues across the organization to help drive a content and brand strategy focused on the goal of acquiring new customers, expanding current customer accounts, and establishing OpenGov as a thought leader for 21st-century public sector innovation. The Senior Content Marketing...


  • Chicago, United States The Rockridge Group Full time

    Job DescriptionJob DescriptionTITLE: SENIOR PAYROLL SPECIALISTLOCATION: CHICAGO Position Summary: Client X is seeking a detailed oriented and organized Senior Payroll Specialist to join the Chicago office. Reporting to Payroll Manager, this person will assist in the administration of payroll with primary emphasis on payroll processing, reporting and data...


  • Chicago, United States OpenGov Inc. Full time

    Job Summary:The Senior Content Marketing Specialist will work closely with colleagues across the organization to help drive a content and brand strategy focused on the goal of acquiring new customers, expanding current customer accounts, and establishing OpenGov as a thought leader for 21st-century public sector innovation. The Senior Content Marketing...


  • 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...