Principal Specialist, Analytical Method Validation

Full Time
Yes
Shift
Normal 9 am 5 pm, no shift work
Duties:
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

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