Lab Quality & Regulatory Specialist

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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

The Lab Quality & Regulatory Specialist is responsible for ensuring regulatory compliance in the clinical laboratory including maintaining laboratory licensure serve as point of contact with laboratory regulatory agencies & facilitate and support in preparation of internal & external audits. The Lab Quality & Regulatory Specialist will assist in the development of the quality management system and support continuous improvement opportunities.

Essential Duties

Include but are not limited to the following:

• Under general supervision leads internal audits investigations and/or gap assessments based on laboratory regulatory requirements or operational risk. Maintains laboratory regulatory registrations reporting and formal communications with regulatory bodies such as CLIA CAP FDA ISO and states with specific requirements such as NY CA MD etc. for all laboratories.
• Under general supervision identify and document non-conforming events performs root cause analysis and development of corrective and preventive actions.
• Continuously monitor policies and procedures to ensure the clinical laboratory meets respective standards and regulations.
• Assist with project management for assignments such as gap analysis audits inspections process creation and improvement as needed.
• Support safety walkthroughs of the laboratories and report any deficiencies on a quarterly basis.
• Assist with preparation and facilitation of external inspections and audits.
• Assist in developing and maintaining clinical laboratory policy and procedures in accordance with federal and state guidelines.
• Support the QMS program development and continuous improvement efforts at all laboratories.
• Support the proficiency testing program including reporting results to applicable regulatory agencies as needed.
• Uphold company mission and values through accountability innovation integrity quality and teamwork.
• Support and comply with the companys Quality management System policies and procedures.
• Regular and reliable attendance.
• 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 travel 5% of working time away from work location may include overnight/weekend travel.

Minimum Qualifications

• Bachelors 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 Bachelors degree.
• Aptitude for learning new software programs.
• Demonstrated ability to collaborate across functions with both internal and external stakeholders and to communicate ideas and opinion in a proactive and professional manner.
• Demonstrated understanding of FDA CLIA CAP HIPAA or other regulatory body.
• Demonstrated understanding of specific state regulatory requirements for clinical laboratory operations such as California New York Maryland or Florida.
• Exceptional written and verbal communication skills excellent attention to detail and organization skills.
• 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

• 1 years of experience with quality management systems or regulated environment.
• 1 years of experience with internal or external audits and inspections by regulatory bodies such as CAP NY or ISO.
• Direct experience working with process and project implementation management or improvement.

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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