GLP Quality Assurance Specialist

Added
5 days ago
Type
Full time
Salary
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Related skills

quality assurance iso glp google docs google drive

πŸ“‹ Description

  • Maintain copies of all approved protocols
  • Maintain a master schedule of all GLP-regulated studies
  • Perform pre-qualification inspections of testing facilities
  • Review study protocols to ensure compliance before initiation
  • Verify final study reports reflect raw data, methods, and SOPs
  • Serve as point of contact for FDA inspections

🎯 Requirements

  • Bachelor of Science in science/engineering/quality field
  • 1+ year in a medical device or life sciences org
  • 1+ year regulatory environment experience
  • 1+ year FDA regulations experience
  • Proficiency in Google Docs, Google Drive, and Gmail
  • Ability to travel to/from multistate locations

🎁 Benefits

  • Growth potential and outsized impact
  • Excellent medical, dental, and vision insurance
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity (RSUs) for full-time employees
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