Clinical Laboratory Qa Specialist

175

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
Understanding of fda clia cap hipaa regulations
** Exact Sciences is seeking a Clinical Laboratory QA Specialist to join their team in Madison, WI. This hybrid role focuses on maintaining quality management systems and ensuring regulatory compliance within the clinical laboratory setting. **

Job Summary

  • The Clinical Laboratory QA Specialist is responsible for maintaining the quality management system and ensuring compliance with all regulatory requirements.
  • This role involves reviewing non-conforming events, conducting investigations, performing root cause analysis, and implementing corrective actions.
  • Exact Sciences offers robust benefits including paid time off, health coverage, and a retirement savings plan to support employees.

Matching Summary

Match Score: 75

** Exact Sciences is seeking a Clinical Laboratory QA Specialist to join their team in Madison, WI. This hybrid role focuses on maintaining quality management systems and ensuring regulatory compliance within the clinical laboratory setting. **

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
  • Understanding of FDA CLIA CAP HIPAA regulations
  • Knowledge of state regulatory requirements for labs
  • Proficiency in Microsoft Office programs

Nice-to-have

  • Experience with audits by regulatory bodies
  • Experience working with laboratory information systems
  • Experience using Epic software
  • Collaboration across internal and external stakeholders
  • Inclusion mindset and proactive communication skills

Key Requirements

  • Bachelor's degree in scientific field or equivalent experience
  • Minimum 2 years quality assurance experience
  • Authorization to work in the US without sponsorship

Work Rights

Must be authorized to work in the US

Tailored Resume

Cover Letter