Development Scientist II, Analytical Development and Clinical QC (ADQC)
USD 109K-163K (estimate) Entry-level Full Time
Tasks
- Design investigational testing plans
- Drive root cause analysis for OOS OOT and atypical results
- Facilitate cross functional quality assurance meetings
- Implement corrective/preventive actions
- Lead investigation closure within quality system
- Manage laboratory investigations
- Recommend process improvements for cGMP compliance
- Review analytical data for assay performance
- Track investigation timelines and targets
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Method Development | CGMP | Cause analysis | Corrective and Preventive Actions | Data review | EU regulations | FDA Regulations | ICH Guidelines | JMP | LIMS | Management systems | Method Development | Microsoft Excel | Microsoft PowerPoint | Microsoft SharePoint | Microsoft Word | Out of Specification | Out of Trend | Pharmaceutical Quality | Preventive actions | Quality Assurance | Quality Management Systems | Quality management | Risk Assessment | Root Cause Analysis | Root cause | SAS | Statistical Analysis | Tableau | Veeva | Veeva Vault
Education
Regions
Countries
States
Cities
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