Regulatory Compliance Specialist

6 days ago


Omaha, Nebraska, United States Validation & Engineering Group Full time
Job Description

The Validation & Engineering Group is a leading services supplier providing solutions for various industries, including Pharmaceutical, Animal Health, Biotechnology, Chemical, Food, and Medical Devices. We are seeking a talented individual to join our team as a Method Validation SME.

Job Responsibilities:

  • Develop, validate, and verify analytical methods.
  • Provide regulatory guidance to ensure compliance with FDA and USDA regulations.
  • Review and evaluate existing methods for improvement opportunities.
  • Prepare validation protocols, reports, and documentation for regulatory submissions.
  • Ensure laboratory compliance with GLP, FDA, USDA, and other applicable regulations.

Required Skills:

  • Bachelor's degree in Chemistry, Biology, or a related field.
  • Minimum of 5-7 years of experience in method development and validation.
  • Knowledge of FDA and USDA regulations.
  • Proven experience with analytical techniques.
  • Strong technical writing and documentation skills.
  • Ability to work independently and collaboratively.

Benefits: Competitive salary, benefits package, and opportunities for growth and professional development.

Estimated Salary Range: $90,000 - $130,000 per year.



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