Quality Assurance Specialist III
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
This position is field based at the Exact Science’s physical location in Phoenix, AZ. The candidate 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 candidate must track quality assurance metrics and monitor effectiveness of the quality management system, support continuous improvement opportunities, and educate the workforce on applicable procedures and regulations.
Essential Duties
Include, but are not limited to, the following:
- Assist with development and management of quality improvement initiatives, quality metrics, and corrective and preventative action.
- 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 and states with specific requirements, such as NY, CA, MD, and FL.
- Review and document non-conforming events, conduct investigations, perform root cause analysis, and develop corrective and preventive actions.
- Assist with training of management and staff on compliance and quality management tools as needed.
- Assist in the development of additional Quality Assurance and Improvement initiatives as needed.
- Assist with coordinating and supporting external audits/inspections of vendors per contractual requirements.
- Assist with project management for assignments, such as gap analysis, risk management, document control, audits, inspections, process creation and improvement as needed.
- Assist with training on compliance and quality management tools to management and staff as needed.
- Participate in laboratory change management process and assist with reviewing and approving documentation.
- Display teamwork and collaborative skills.
- Provide insightful feedback.
- 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.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work nights and/or weekends, 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 work on a computer and phone simultaneously.
- Ability to use a telephone through a headset.
- Ability to work seated for approximately 90% of a typical working day. Ability to work standing for approximately 10% of a typical working day.
- Ability to lift up to 5 pounds for approximately 10% of a typical working day.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to comply with any applicable personal protective equipment requirements.
Minimum Qualifications
- Bachelor’s Degree in laboratory science or related field.
- 5+ years of work experience.
- 4+ years of experience in a clinical lab setting in a technical, QA or Compliance role.
- Experience in conducting audits of diagnostic/CRO laboratories.
- Demonstrated knowledge of HIPAA.
- 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
- National certification (ASCP, CQE or equivalent).
- CLIA and Quality Management Systems (QMS), Knowledge of CAP.
Salary Range:
$85,000.00 - $135,000.00The annual base salary shown is for this position located in US - AZ - Phoenix on a full-time basis. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.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 neo@exactsciences.com.
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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.
