Regulatory Compliance Specialist
6 days ago
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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