Assay Validation Specialist
Job Summary
Position : Assay Validation Specialist.
Location : Athens, GA, USA
Duration : 12 Months
Schedule : Full-time, standard hours (9 AM – 5 PM)
Key Responsibilities
• Develop analytical method validation protocols aligned with FDA, EU, USDA regulations and corporate standards
• Oversee validation projects and coordinate lab testing
• Compile and summarize validation results in formal reports
• Collaborate with area managers on project timelines, regulatory documentation, and USDA submissions
Required Skills & Experience
• Strong background in analytical and regulatory method validation (USDA, ICH, FDA)
• Preferred experience with:
• Change control documentation and impact assessments
• Indirect Fluorescent Antibody (IFA) testing
• Laboratory or production facility operations
• Solid understanding of microbiology, biochemistry, and pharmaceutical quality standards
• Familiarity with GLP/GMP and other regulatory practices
• Effective written and verbal communication of technical data
Education
• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, or related scientific field.
Pharmaceutical Manufacturing and Biotechnology Research
Production and Manufacturing
Contract