Senior Analytical Method Validation Specialist

3 weeks ago


Omaha, Nebraska, United States Validation & Engineering Group Full time
Job Title:
Senior Analytical Method Validation Specialist

We are seeking a highly skilled and experienced Senior Analytical Method Validation Specialist to join our team at Validation & Engineering Group. This role will involve providing expert technical guidance on the development, validation, and optimization of analytical methods in support of our clients in the animal health industry.

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 including quality assurance, regulatory affairs, and laboratory personnel to provide subject matter expertise and ensure project milestones are met.

Requirements:
To be successful in this role, you will need a Bachelor's degree in Chemistry, Biology, or a related field (Master's or PhD preferred). You should also have minimum 5-7 years of experience in method development and validation within a regulated environment, preferably in the animal health, pharmaceutical, or biotech industries. Additionally, you should have knowledge of FDA and USDA regulations applicable to analytical method validation, as well as strong technical writing and documentation skills.

Salary:
The estimated salary for this position is between $80,000 and $110,000 per year, depending on qualifications and experience.

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