Principal Specialist, Analytical Method Validation
Pay range: 20-28/hr
*depending on experience
• Write analytical method validation protocol in compliance with all applicable FDA/EU/USDA regulations as well as corporate procedures • Provide oversight of validation project and coordinate with laboratory experimental test execution • Summarize laboratory validation test results in validation report • Collaborate with the area manager(s) for project management, project timelines, regulatory documentation and final reports for submission to the USDA Skills:
- Experience with analytical method validation and regulatory method validation requirements (USDA, ICH, FDA)
- Preferred experience in writing change controls and conducting impact assessments
- Preferred experience with Indirect Fluorescent Antibody (IFA) Test methodology
- Working knowledge and basic theoretical understanding of scientific principles (e.g. microbiology, biological chemistry, biochemistry)
- Laboratory and/or Production facility experience preferred
- Basic knowledge of pharmaceutical quality
- Comprehension of Good Laboratory or Manufacturing Practice (GLP/GMP) and other applicable regulations
- Written and verbal communications of technical information
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