Lab Quality & Regulatory Specialist in Madison, WI | BS Science Candidates Apply Now
Looking for a purpose-driven career in the clinical laboratory field? Exact Sciences is seeking a Lab Quality & Regulatory Specialist in Madison, to ensure regulatory compliance, support audits, and drive continuous improvement. Be part of a mission-focused team helping change how the world prevents and detects cancer.
About Exact Sciences:
At Exact Sciences, we’re helping change how the world prevents, detects, and guides treatment for cancer. We provide patients and clinicians with the clarity needed to make confident decisions when they matter most. Join our team for a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
Job Description:
- Location: US – WI – Madison
- Employment Type: Full-Time
- Posted On: Today
- Job Requisition ID: R25-10523
Position Overview:
The Lab Quality & Regulatory Specialist is responsible for ensuring regulatory compliance in the clinical laboratory, including maintaining laboratory licensure, serving as the point of contact with laboratory regulatory agencies, and facilitating and supporting in the preparation of internal and external audits. The Specialist will assist in the development of the quality management system and support continuous improvement opportunities.
Essential Duties:
- As a Lab Quality & Regulatory Specialist you should lead internal audits, investigations, and gap assessments according to regulatory requirements.
- Maintain laboratory registrations and communications with CLIA, CAP, FDA, ISO, and state-specific agencies (NY, CA, MD).
- Identify non-conforming events, perform root cause analysis, and develop corrective and preventive actions.
- Monitor policies and procedures to maintain laboratory standards and compliance.
- In Exact Sciences. you should assist with project management for audits, inspections, and process improvements.
- Conduct laboratory safety walkthroughs and report deficiencies quarterly.
- Support proficiency testing and QMS program development.
- Uphold company values: accountability, innovation, integrity, quality, and teamwork.
Minimum Qualifications:
- Bachelor’s degree in a scientific field and 2+ years in quality assurance or QMS in a regulated environment, or high school diploma with 4+ years relevant experience.
- Strong understanding of FDA, CLIA, CAP, HIPAA, and state regulatory requirements.
- Excellent written and verbal communication, attention to detail, and organizational skills.
- Authorization to work in the U.S. without sponsorship.
Preferred Qualifications:
- 1+ years of experience with quality management systems or regulated environment.
- With this Lab Quality & Regulatory Specialist you get direct experience working with process and project implementation, management, or improvement.
- Experience with internal or external audits and inspections by regulatory bodies.
Salary Range: $74,000.00 – $122,000.00 annual base salary for this position located in US – WI – Madison on a full-time basis. Bonus eligible.
Note: Exact Sciences offers an employee experience that includes paid time off, a retirement savings plan, wellness support, accommodation and health benefits.
