Clinical Laboratory QA Specialist

Exact Sciences • Madison, WI

2d • $74,000 - $122,000 • Hybrid

About The Position

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.

Requirements

• 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.
• Demonstrated understanding of FDA, CLIA, CAP, HIPAA, or other regulatory body.
• Proficient in Microsoft Office programs.
• Demonstrated aptitude for learning new software.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.

Nice To Haves

• 1+ years of experience with quality management systems in a regulated environment 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.
• Experience with HIPAA regulations.
• Experience using and working in Epic.

Responsibilities

• 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.

Benefits

• Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level