Analytical Test Technician

Position Title: Principal Specialist, Analytical Method Validation Assignment Duration: 12 Months Work Location - Athens, GA 30601 Work Schedule: Normal 9 am – 5 pm Key Responsibilities: 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 Qualification Experience: 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 Bachelor's degree in a relevant scientific discipline (e.g. Biology, Microbiology, Chemistry, Biochemistry) Key Responsibilities: 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