Joulé
Job Title: Analytical Method Validation Specialist Location: Athens, GA Hours/Schedule: 9am- 5pm Type: Contract Overview Global pharma company looking to bring on an entry to mid level Analytical Method Validation Specialist to their growing team. Must bring a BS Degree and experience with analytical method validation and regulatory method validation requirements. 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 Requirements 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 Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Ref: #558-Scientific