Development Scientist II, Analytical Development and Clinical QC (ADQC)
USD 110K-166K (estimate) Senior-level Full Time
Tasks
- Close Out of Trend investigations with root cause analysis
- Coordinate compliant investigation timelines and reporting
- Develop investigational testing plans
- Lead cross functional investigation meetings
- Manage laboratory investigations for Out of Specification results
- Recommend system improvements for cGMP compliance
- Review analytical data for assay performance
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Data | Analytical Data Review | Analytical Development | Biological Analytical Development | Box | CAPA | CGMP | Cause analysis | Corrective preventive action | Data review | FDA Regulations | ICH Guidelines | JMP | KNEAT | LIMS | Laboratory investigations | Management System | Microsoft Excel | Microsoft PowerPoint | Microsoft SharePoint | Microsoft Word | Out of Specification | Out of Trend | Preventive Action | Quality Management System | Quality management | Risk Assessment | Root Cause Analysis | Root cause | SAS | Tableau | ValGenesis | Validated Documentation | Veeva Vault
Education
Regions
Countries
States
Cities
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