Exact Sciences Corporation

Clinical Laboratory Quality Assurance Specialist

Job Locations US-WI-Madison | US-WI-Madison
Req No.
2021-9002
Category
Quality Assurance & Regulatory Affairs
Type
Regular Full-Time

Summary of Major Responsibilities

The Clinical Laboratory Quality Assurance (QA) Specialist is responsible for many quality issues in the clinical laboratory, including developing, implementing, and maintaining a quality management system, ensuring compliance with all regulatory requirements, and facilitating feedback monitoring and resolution for customer satisfaction, and non-conforming event management. The Clinical Laboratory QA Specialist will monitor effectiveness of the quality management system, support continuous improvement opportunities, and educate the workforce on applicable procedures and regulations.

Essential Duties and Responsibilities

  • Assist in developing and maintaining clinical laboratory QA plans, policies, processes, and procedures in accordance with federal and state guidelines, and support the Proficiency Testing program, policy development, and training.
  • Monitor continuously policies and procedures to ensure the clinical laboratory meets respective standards and regulations; support regulatory registrations, inspections, reporting, and formal communications with CLIA, CAP, FDA, and states with specific requirements, such as New York, California, Maryland, and Florida.
  • Assist in developing laboratory-based metrics to measure efficacy of the quality system, and provide visibility for management oversight; ensure quality system robustness through internal audits/investigations, evaluations, process implementation, and continuous improvement opportunities.
  • Review and document nonconforming events, conduct investigations, perform root cause analysis, and develop 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.
  • Work with the privacy officer and cross-departmental staff to provide training 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.
  • Assist with project management for assignments, such as gap analysis, risk management, document control, audits, inspections, process creation, and improvement, as needed.
  • 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.

Qualifications

Minimum Qualifications

  • Bachelor’s degree in a Science or field as outlined in essential duties.
  • 3+ years of experience in quality management system and assurance.
  • Demonstrated understanding and professional working knowledge of FDA, CLIA, CAP, HIPAA, or other regulatory body.
  • 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 Science field or field as outlined in essential duties.
  • 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 working with process and project implementation, management, or improvement.
  • Experience in a quality assurance role in a regulated environment.
  • Additional certifications in Six Sigma or quality assurance.

#LI-DP1

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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