Validation Specialist

Description

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

Education: 

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