What are the responsibilities and job description for the Analytical Method Validation Specialist position at Aequor?
Job Title: Analytical Method Validation Specialist
Location: Athens, GA (onsite)
Duration: 12 months contract will be extended.
Shift: 1st shift, 9 am - 5 pm.
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).
Working knowledge and basic theoretical understanding of scientific principles (e.g., microbiology, biological chemistry, biochemistry).
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.
Preferred experience in writing change controls and conducting impact assessments.
Preferred experience with Indirect Fluorescent Antibody (IFA) Test methodology.
Laboratory and/or Production facility experience preferred.
Education:
Bachelor's degree in a relevant scientific discipline (e.g., Biology, Microbiology, Chemistry, Biochemistry).
