Analytical Chemist

Title : Principal Specialist, Analytical Method Validation

Contract 12 Months contract

Location : Athens, GA

Jobs 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

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

Education:

Bachelor's degree in a relevant scientific discipline (e.g. Biology, Microbiology, Chemistry, Biochemistry)