What are the responsibilities and job description for the Junior analytical method validation position at Fladger Associates?
Responsibilities:
- Excellent employment opportunity for a Principal Specialist, Analytical Method Validation in the Athens, GA area.
- Shift: 9 am – 5 pm, no shift work
- 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:
- Bachelor's degree in a relevant scientific discipline (e.g. Biology, Microbiology, Chemistry, Biochemistry)
- 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
