Principal Specialist, Analytical Method Validation

Duration: 12 Months Contract

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)

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Swati

Email: swati.tiwari@ustechsolutionsinc.com

Internal Id: 25-49473