Development Scientist III, Analytical Development and Clinical QC
US - New Haven - CT, United States
USD 110K-166K Senior-level Full Time
Tasks
- Coordinate release stability in process and impurity testing
- Ensure GMP and GxP compliant testing
- Ensure timely closure in quality system
- Lead assay troubleshooting
- Lead laboratory investigations of OOS OOT and atypical results
- Manage analytical change control updates
- Manage electronic record upload to quality system
- Manage sample logistics
- Oversee outsourced analytical testing
- Perform CAPA development and execution
- Perform root cause analysis
- Review and approve analytical methods
- Review and approve release stability and PPQ testing protocols
- Update validation and transfer reports
Perks/Benefits
- Dental insurance
- Health insurance
- Paid time off
- Retirement benefits
- Travel 10 percent
- Vision insurance
Skills/Tech-stack
ALCOA | ALCOA+ | Analytical method lifecycle | Analytical method validation | CAPA | Cause analysis | Change Control | Corrective and Preventive Actions | Data Integrity | Data Management | EU regulations | Electronic Data | Electronic data management | FDA Regulations | GMP | GxP | ICH Guidelines | Impurity testing | In Process Testing | Laboratory investigations | Management System | Method validation | Microsoft Excel | Microsoft PowerPoint | Microsoft Word | Out of Specification | Out of Trend | Pharmaceutical Quality | Pharmaceutical Quality Assurance | Preventive actions | Process testing | Quality Assurance | Quality Management System | Quality management | Release testing | Risk Assessment | Root Cause Analysis | Root cause | Stability Testing
Education
Regions
Countries
States
Cities
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