Scientist I, Analytical Development and Quality Control
About this role
About the Role The Scientist I, Analytical Development and Quality Control supports analytical quality control, method validations, stability programs, and data integrity within the AD/QC organization. This role contributes to release and stability testing, data trending, and lifecycle management of analytical methods to ensure product quality and regulatory compliance. What You'll Do
- Analyze and trend release and stability data to identify variability, shifts, and emerging quality risks, and communicate findings to departmental leadership and project teams.
- Review release and stability test results to ensure accuracy, completeness, and compliance with specifications, procedures, GMP requirements, and overall data integrity.
- Execute and support registration stability programs, including protocol implementation, sample management, and data evaluation across timepoints.
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