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Clinical Trials Associate

Worldwide Clinical Trials · Seoul, South Korea

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Clinical OperationsFull-time$78k–$129kCompany career page

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What they're looking for

  • Bachelor's degree in biology, microbiology, or engineering
  • Minimum 5 years sterility assurance or quality assurance experience in GMP manufacturing
  • In-depth knowledge of EU GMP Annex 1 and FDA cGMP regulations
  • Proven experience planning and executing aseptic process validations and media fills
  • Knowledge of sterilization methods, bioburden testing, endotoxin testing, and contamination control
  • Experience with risk management methodologies such as FMEA or HACCP
  • Strong analytical, problem-solving, and project management capabilities

What you'll be doing

  • Develop, implement, and oversee sterility assurance policies, procedures, and documentation
  • Lead validation and monitoring of sterilization processes, aseptic processing, and environmental controls
  • Plan, execute, and approve aseptic process simulations ensuring regulatory compliance
  • Manage deviation investigations, root cause analysis, and corrective action plans related to sterility
  • Support regulatory inspections and audits as subject matter expert; stay current on industry advances

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