Principal Specialist, Analytical Method Validation
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Job Location:
Athens, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Athens GA
Contract Duration: 12-36 months
Rate: Negotiable
Responsibilities:
- Excellent employment opportunity for a Principal Specialist Analytical Method Validation in the Athens GA area.
- Shift: 9 am 5 pm no shift work
- 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
- Bachelors degree in a relevant scientific discipline (e.g. Biology Microbiology Chemistry Biochemistry)
- 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
Key Skills
- Airside Operations
- Accountancy
- Data Warehousing
- Actuary
- Import & Export
- Corrosion
