Principal Specialist, Analytical Method Validation

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)

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 27.00/hr.