Clinical Laboratory QA Specialist

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Position Overview

The Clinical Laboratory Quality Assurance (QA) Specialist is responsible for many quality aspects in the clinical laboratory including developing, implementing, and maintaining a quality management system, ensuring compliance with all regulatory requirements. The Clinical Laboratory QA Specialist will monitor effectiveness of the quality management system, identify, support, and facilitate continuous improvement opportunities, and educate the workforce on applicable procedures and regulations.

Essential Duties

Include, but are not limited to, the following:

• Continuously monitor and maintain policies and procedures to ensure the clinical laboratory meets respective standards and regulations, such as CAP, CLIA, New York, California, Maryland, and Florida.

• Develop laboratory-based metrics to measure efficacy of the quality system and provide visibility for management oversight.

• Review and document nonconforming events, conduct investigations, perform root cause analysis, and develop and implement corrective and preventive actions.

• Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback; coordinate processes, reports, and documentation for escalations arising from feedback.

• Review, investigate, evaluate, and maintain patient medical records.

• Work with the privacy office and cross-departmental staff to provide guidance and awareness of health insurance portability and accountability act (HIPAA), protection of patient data, pertinent regulations and requirements, and relevant quality system policies and procedures.

• Ensure quality system robustness and laboratory readiness through assisting with internal audits/investigations.

• Project management for process creations, improvement, and harmonization.

• Apply exceptional written and verbal communication skills.

• Strong attention to detail, organization, and record-keeping skills.

• Ability to collaborate across functions and with both internal and external stakeholders.

• Strong leadership and decision-making skills.

• Ability to communicate ideas, opinions, and counter arguments in a proactive and professional manner.

• 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 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.

Minimum Qualifications

• Bachelor's degree in a scientific major or related field and 3 years of experience in quality assurance (or quality management system) in a regulated environment.

• Demonstrated understanding and professional working knowledge 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.

• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Advanced degree in a scientific field.

• Experience with or demonstrated understanding of specific state regulatory requirements for clinical laboratory operations, such as California, New York, Maryland, or Florida.

• Experience with audits or inspections by regulatory bodies, such as CAP, NY, or FDA.

• Experience in a quality assurance role in a regulated environment.

• Additional certifications in Six Sigma or quality assurance.

Salary Range:

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. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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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. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.