Development Scientist II, Analytical Development and Clinical QC (ADQC)
US - New Haven - CT, United States
USD 107K-163K (estimate) Senior-level Full Time
Tasks
- Assess assay performance
- Design investigational testing plans
- Drive corrective actions and preventive actions
- Ensure compliant closure in quality system
- Facilitate cross functional quality meetings
- Generate laboratory investigations
- Identify systems improvement opportunities
- Lead root cause analysis
- Mirror and review investigations
- Perform impact assessment
- Present investigation findings
- Recommend cGMP compliant changes
- Review analytical data
- Track investigation timelines
Perks/Benefits
Skills/Tech-stack
Analytical Data | Analytical Data Review | Assay Performance Evaluation | CGMP | Cause analysis | Corrective and Preventive Actions | Data review | EU regulations | FDA Regulations | GMP | ICH Guidelines | Information Management System | Laboratory Information Management | Laboratory Information Management System | Laboratory information | Management System | Microsoft Excel | Microsoft PowerPoint | Microsoft Word | Out Of Specification Investigation | Out Of Trend Investigation | Out of Specification | Out of Trend | Performance Evaluation | Preventive actions | Quality Management System | Quality management | Risk Assessment | Root Cause Analysis | Root cause | Trend investigation | Validated Documentation | Veeva Vault
Education
Regions
Countries
States
Cities
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