What are the responsibilities and job description for the Principal Specialist, Analytical Method Validation position at Jobs via Dice?
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We are looking for Principal Specialist, Analytical Method Validation for our client in Athens, GA
Job Title: Principal Specialist, Analytical Method Validation
Job Location: Athens, GA
Job Type: Contract
Job Description:
Duties:
We are looking for Principal Specialist, Analytical Method Validation for our client in Athens, GA
Job Title: Principal Specialist, Analytical Method Validation
Job Location: Athens, GA
Job Type: Contract
Job Description:
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.
- 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).
