Clinical Laboratory QA Specialist

Help us change lives

At Exact Sciences were helpingchange 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 youre working to help others.

Position Overview

This position is field based at the Exact Sciences physical location in Phoenix AZ. The candidate will track quality assurance metrics as part of the Laboratory Quality Management System. The candidate will maintain records and documents for regulatory audits. The candidate will assist with documentation of process improvements non-conformance and corrective/preventative actions. Lastly the candidate will be responsible for conducting internal Quality Assurance Audits and proposing process improvements based on findings.

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.
• Performs monthly internal Quality Assurance audits. Documents findings and proposes process improvements based on findings.
• Assist with documentation of non-conformances and corrective and preventative actions.
• Assist with proficiency testing coordination documentation and tracking.
• Assist with coordinating and supporting external audits/inspections of vendors per contractual requirements.
• Assist with training on compliance and quality management tools to management and staff as needed.
• Assist with the development of additional Quality Assurance and Improvement initiatives 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 companys 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 seated for approximately 90% of a typical working day. Ability to work standing for approximately 10% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.

Minimum Qualifications

• Bachelors Degree in laboratory science or related field.
• 4 years of work experience.
• 3 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:

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 disability protected veteran status and any other status protected by applicable local state or federal law.

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