Clinical Laboratory Quality Assurance Associate

    • Madison, WI

Summary of Major Responsibilities

The Clinical Laboratory Quality Assurance (QA) Associate is responsible for many quality aspects in the clinical laboratory, including supporting and maintaining the quality management system, ensuring compliance with all regulatory requirements, facilitating feedback monitoring and resolution for customer satisfaction, and non-conforming event management. The QA Associate will assist in monitoring effectiveness of the quality management system and provide visibility through data and metric reporting.

Essential Duties and Responsibilities

  • Assists to maintain clinical laboratory QA plans, policies, processes, and procedures in accordance with federal and state guidelines, and supports the Proficiency Testing program, policy development, and training.
  • Support the monitoring of policies and procedures to ensure the clinical laboratory meets respective standards and regulations; supports regulatory registrations, inspections, reporting and formal communications with CLIA, CAP, FDA and states with specific requirements, such as NY, CA, MD, and FL.
  • Generate laboratory-based metrics to measure efficacy of the quality system and prepares periodic metrics reporting for management oversight.
  • Review and document non-conforming events, conducts investigations, performs root cause analysis, and development of corrective and preventive actions.
  • Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback, interacts with representative from the Customer Care Center for follow-up; assists in gathering documentation to support feedback escalations.
  • Exceptional written and verbal communication skills.
  • Strong attention to detail, organization, and record-keeping skills.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Regular and reliable attendance.
  • Ability to work designated schedule.
  • Ability to work overtime as needed.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
  • Ability to comply with any applicable personal protective equipment requirements.
  • May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
  • Ability and means to travel between Madison locations.

Qualifications

Minimum Qualifications

  • Bachelor’s degree in a scientific major or related field.
  • 2+ years of experience in a quality-oriented environment.
  • Basic computer skills to include Internet navigation, Email usage, and word processing.
  • Proficient in Microsoft Office to include Excel macros and pivot tables and Word mail merge.
  • Demonstrated ability to collaborate across functions and with both internal and external stakeholders, and to communicate ideas and opinions in a proactive and professional manner.
  • Demonstrated understanding of specific state regulatory requirements for clinical laboratory operations, such as CA, NY, MD or FL.
  • Working knowledge of FDA, CLIA, and CAP.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
  • Authorization to work in the United States without sponsorship.

Preferred Qualifications

  • 1+ years of experience with quality management systems or certifications in quality assurance.
  • 1+ years of experience with audits or inspections by regulatory bodies, such as CAP, NY or FDA.
  • 1+ years of experience working with a Laboratory Information System, and past experience with HIPAA regulations.

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EEO Disclosure

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.


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