Di/qc & Admin Lead

Auris Health, Inc.

Santa Clara, CA, United States of America
Base: $150,000 - $170,000; bonus/equity: not speci...
Hybrid
21 cfr part 58 laboratory compliance
Quality control processes and procedures
Data integrity review
Support execution of preclinical studies required to competitively position robotic and digital solutions for regulatory approval and clinical acceptance

Job Summary

  • Support execution of preclinical studies required to competitively position robotic and digital solutions for regulatory approval and clinical acceptance.
  • Implement Quality Control processes and procedures spanning from implementing quality standards through developing internal processes to optimize the quality control function in support of compliance under 21 CFR 58.
  • Responsible for resourcing of lab activities and facility utilization.

Matching Summary

Support execution of preclinical studies required to competitively position robotic and digital solutions for regulatory approval and clinical acceptance.

Salary

Base: $150,000 - $170,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 21 CFR Part 58 laboratory compliance
  • Quality Control processes and procedures
  • data integrity review
  • GLP program support
  • equipment maintenance and calibration
  • internal system inspections

Nice-to-have

  • Subject Matter Expert on 21 CFR Part 58
  • continuous quality improvement
  • inclusive work environment

Key Requirements

  • Master's degree in Biotechnology or related field
  • 2 years of experience in DI/QC & Admin Lead-related occupation

Work Rights

Not specified

Tailored Resume

Cover Letter