Principal Specialist, Analytical Method Validation
Planet Pharma
Date: 7 hours ago
City: Athens, GA
Contract type: Full time
Job Description
Pay range: 20-28/hr
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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
- 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
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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