Clinical Laboratory Qa Specialist

Exact Sciences

Madison, WI, US
Base: $74,000.00 - $122,000.00; bonus/equity: bonu...
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Bachelor's degree in scientific major
2+ years qa experience in regulated environment
Knowledge of fda clia cap hipaa regulations
** Exact Sciences is seeking a Clinical Laboratory QA Specialist in Madison, WI, for a hybrid role focused on maintaining quality management systems, ensuring compliance, and facilitating process improvements in a clinical laboratory setting. The position requires a scientific background and experience in quality assurance within regulated environments. **

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 per week at the Madison, WI location with a standard Monday to Friday schedule.
  • Exact Sciences offers robust benefits including paid time off, health coverage, and a retirement savings plan alongside a competitive salary range.

Matching Summary

Match Score: 75

** Exact Sciences is seeking a Clinical Laboratory QA Specialist in Madison, WI, for a hybrid role focused on maintaining quality management systems, ensuring compliance, and facilitating process improvements in a clinical laboratory setting. The position requires a scientific background and experience in quality assurance within regulated environments. **

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
  • Proficiency in Microsoft Office programs

Nice-to-have

  • Experience with audits or inspections
  • Experience with laboratory information systems
  • Experience working with Epic software
  • Collaboration across internal and external stakeholders
  • Proactive communication skills

Key Requirements

  • Bachelor's degree in scientific field or equivalent experience
  • Minimum 2 years quality assurance experience
  • Understanding of FDA, CLIA, CAP, and HIPAA standards
  • Authorization to work in the US without sponsorship

Work Rights

Must be authorized to work in the US

Tailored Resume

Cover Letter