Analytical Method Validation Expert

4 days ago


Omaha, Nebraska, United States Validation & Engineering Group Full time
Job Description:
The Validation & Engineering Group is seeking a highly skilled Analytical Method Validation Expert to join our team. This role involves providing expert technical and regulatory guidance on the development, validation, and optimization of analytical methods in support of a client in the animal health industry. The successful candidate will be responsible for ensuring compliance with FDA and USDA regulations while ensuring the methods are fit for purpose within a Good Laboratory Practice (GLP) environment.

Key Responsibilities:

  • Lead the development, validation, and verification of analytical methods, including assays, potency tests, and other relevant tests required by the animal health industry.
  • Provide regulatory guidance to ensure adherence to FDA and USDA requirements throughout the method validation process.
  • Review and evaluate existing methods for improvement opportunities and ensure they meet current regulatory standards.
  • Prepare validation protocols, reports, and documentation required for regulatory submissions.
  • Ensure laboratory compliance with GLP, FDA, USDA, and other applicable regulations, policies, and guidelines.
  • Collaborate with cross-functional teams to provide subject matter expertise and ensure project milestones are met.
  • Conduct troubleshooting, risk assessments, and technical evaluations as needed to address method performance issues.

Salary: $85,000 - $110,000 per annum, depending on experience.



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