Development Scientist II, Analytical Development and Clinical QC (ADQC)
US - New Haven - CT, United States
USD 110K-166K (estimate) Senior-level Full Time
Tasks
- Assess impact for atypical results
- Close out out of specification findings
- Close out out of trend findings
- Develop investigation testing plans
- Drive laboratory investigations
- Ensure compliant LIR closure
- Lead cross-functional meetings
- Manage corrective preventive actions
- Perform root cause analysis
- Recommend process improvements for compliance
- Review analytical data
- Track investigation timelines and targets
Perks/Benefits
Skills/Tech-stack
Analytical testing | CGMP | Cause analysis | Corrective preventive action | Data Analysis | FDA Regulations | ICH Guidelines | JMP | LIMS | Management System | Microsoft Excel | Microsoft PowerPoint | Microsoft SharePoint | Microsoft Word | Pharmaceutical Quality | Pharmaceutical Quality Assurance | Preventive Action | Quality Assurance | Quality Management System | Quality management | Risk Assessment | Root Cause Analysis | Root cause | SAS | Statistical Analysis | Tableau | Veeva | Veeva Vault
Education
Roles
Regions
Countries
States
Cities
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