Quality Assurance Specialist

Natera

Remote, US
Remote
Bachelor's degree in life sciences or engineering
5+ years biotech industry experience
Knowledge of fda, iso13485, clia, cap regulations
Natera is seeking a Quality Assurance Specialist to support their operations remotely. The ideal candidate will have experience in the biotech industry, particularly with quality systems management and relevant regulatory compliance

Job Summary

  • The Quality Assurance Specialist ensures safety, quality, and compliance with all relevant procedures, state and federal regulations, and customer expectations.
  • Natera is a global leader in cell-free DNA testing dedicated to oncology, women's health, and organ health.
  • Employees receive comprehensive benefits including free genetic testing, fertility care benefits, and generous employee referral programs.

Matching Summary

Match Score: 85

Natera is seeking a Quality Assurance Specialist to support their operations remotely. The ideal candidate will have experience in the biotech industry, particularly with quality systems management and relevant regulatory compliance.

Skills & Requirements

Must-have

  • Bachelor's Degree in Life Sciences or Engineering
  • 5+ years Biotech industry experience
  • Knowledge of FDA, ISO13485, CLIA, CAP regulations
  • Experience with CCRS, CAPAs, Deviations, SCAR
  • Access to PHI and HIPAA privacy training

Nice-to-have

  • Prior cryopreservation experience
  • Background in cord blood or transfusion medicine
  • Experience with biologics or tissue/organ processing
  • Operational experience in a medical setting

Key Requirements

  • Bachelor's Degree required
  • 5+ years Biotech experience preferred
  • Pass post-offer criminal background check
  • Complete HIPAA/PHI training within 30 days

Work Rights

Not specified

Tailored Resume

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