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John Y. Lee

John Y. Lee, MBA, BA

GMP Compliance Advisor

Mr. Lee has lectured and published extensively on the topics of GMP compliance and auditing, quality assurance, validation, lyophilization, aseptic processing and filtration, clean rooms and pre-approval inspections

John Y. Lee
  • Specializing in:
    • Pharmaceutical GMP compliance consulting
    • Pharmaceutical GMP compliance auditing
    • Quality assurance
    • Qualification and validation
    • GMP compliance training
  • Professional experience:
    • Director, Quality Assurance
      Altana, Inc.
    • Director, Quality Assurance
      Organon, Inc.
    • GMP Compliance Associate
      Ortho Pharmaceuticals
    • Consumer Safety Officer (Investigator)
      U.S. Food & Drug Administration
      East Orange, New Jersey