Development Scientist II, Analytical Development and Clinical QC (ADQC)
US - New Haven - CT, United States
USD 123K-185K (estimate) Senior-level Full Time
Tasks
- Assess impact and drive CAPA closure
- Conduct root cause analysis for OOS OOT and atypical results
- Create and track investigation timelines
- Design investigational testing plans
- Initiate and own laboratory investigations
- Lead cross functional investigation alignment meetings
- Maintain quality compliance for external quality control testing
- Present investigation outcomes
- Recommend process and systems improvements for cGMP compliance
- Review analytical data for assay performance
Perks/Benefits
Skills/Tech-stack
Analytical Data | Analytical Data Review | Box | CGMP | Cause analysis | Corrective and Preventive Actions | Data Analysis | Data review | EU regulations | FDA Regulations | ICH Guidelines | JMP | KNEAT | LIMS | Laboratory investigations | Management systems | Microsoft Excel | Microsoft PowerPoint | Microsoft SharePoint | Microsoft Word | Out of Specification | Out of Trend | Preventive actions | Quality Management Systems | Quality management | Risk Assessment | Root Cause Analysis | Root cause | SAS | Statistical Analysis | Tableau | ValGenesis | Veeva Vault
Education
Roles
Regions
Countries
States
Cities
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