Clinical Laboratory Qa Specialist

Exact Sciences Corporation

Madison, WI, US
Base: $74,000.00 - $122,000.00; bonus/equity: bonu...
Hybrid (minimum of 3 days onsite in madison, wi)
Bachelor's degree in scientific major
2+ years qa experience in regulated environment
Knowledge of fda, clia, cap, hipaa regulations
Exact Sciences Corporation is seeking a Clinical Laboratory QA Specialist to support quality management in their clinical laboratory. The role involves ensuring regulatory compliance, managing non-conforming events, and contributing to process improvement in a hybrid work environment

Job Summary

  • The Clinical Laboratory QA Specialist is responsible for maintaining the quality management system and ensuring compliance with all regulatory requirements.
  • This hybrid role requires onsite presence at least 3 days a week at the Madison, WI location with remote work options for 2 days.
  • Exact Sciences offers robust benefits including paid time off, health coverage, and a retirement savings plan to support employee well-being.

Matching Summary

Match Score: 85

Exact Sciences Corporation is seeking a Clinical Laboratory QA Specialist to support quality management in their clinical laboratory. The role involves ensuring regulatory compliance, managing non-conforming events, and contributing to process improvement in a hybrid work environment.

Salary

Base: $74,000.00 - $122,000.00; Bonus/Equity: Bonus eligible; Benefits: PTO, health, dental, vision, retirement plan

Skills & Requirements

Must-have

  • Bachelor's degree in scientific major
  • 2+ years QA experience in regulated environment
  • Knowledge of FDA, CLIA, CAP, HIPAA regulations
  • Experience with state regulatory requirements
  • Proficient in Microsoft Office programs

Nice-to-have

  • Experience with audits or inspections by regulatory bodies
  • Experience working with a laboratory information system
  • Experience using Epic software
  • Certifications in quality assurance
  • Collaboration across internal and external stakeholders

Key Requirements

  • Bachelor's degree in scientific field or equivalent experience
  • Authorization to work in the US without sponsorship
  • Understanding of specific state regulatory requirements
  • Demonstrated ability to perform root cause analysis

Work Rights

Must be authorized to work in the US

Tailored Resume

Cover Letter