Clinical Laboratory QA Specialist

Clinical Laboratory QA Specialist page is loaded## Clinical Laboratory QA Specialist locations:
US - WI - Madison time type:
Full time posted on:
Posted Yesterday job requisition :
R25-11977
** Help us change lives
** At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
** Position Overview
** The Clinical Laboratory QA Specialist 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. Clinical Laboratory QA Specialist will assist with facilitation of process improvement, process change, and coordination of user awareness within the laboratory departments.
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* Location:

** This is a hybrid role onsite at 1 Exact Lane in Madison, WI a minimum of 3 days/week and remote 2 days.
** Shift:
** Monday - Friday 8:00am - 4:30pm
** Essential Duties
** Include, but are not limited to, the following:
* Support the monitoring and maintenance of policies and procedures to ensure the clinical laboratory meets respective standards and regulations.
* Generate laboratory-based metrics to measure efficacy of the quality system and prepare periodic metrics reporting for management oversight.
* Review and document non-conforming events, conduct investigations, perform root cause analysis, and develop and assist with implementation of corrective and preventive actions.
* Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback.
* Review, investigate, evaluate, and maintain patient medical records.
* Assist in monitoring effectiveness of the quality management system and provide visibility through data and metric reporting.
* Interact with representatives from the customer care center for follow-up and assist in gathering documentation to support feedback escalations.
* Demonstrated ability to collaborate across functions and with both internal and external stakeholders, with emphasis on communicating ideas and opinions in a proactive and professional manner.
* Apply 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.
* Maintain regular and reliable attendance.
* Ability to act with an inclusion mindset and model these behaviors for the organization.
* 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 locations.
** Minimum Qualifications
*** Bachelor’s degree in a scientific major or related field and 2+ years of experience in quality assurance (or quality management system) in a regulated environment; or high school degree/general education diploma and 4+ years of relevant experience with at least 2 years in quality assurance (or quality management system) in a regulated environment in lieu of Bachelor’s degree.
* 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 California, New York, Maryland, or Florida.
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