Development Scientist II, Analytical Development and Clinical QC (ADQC)
USD 109K-166K (estimate) Senior-level Full Time
Tasks
- Close out out of specification results
- Close out out of trend results
- Conduct root cause analysis
- Design investigational testing plans
- Develop investigation closure timelines and plans
- Drive laboratory investigations
- Execute corrective and preventive actions
- Lead cross functional quality meetings
- Perform impact assessment
- Present investigation status and results
- Recommend system improvements for compliance
- Review analytical data
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Data | Analytical Data Review | Biochemistry | Box | CGMP | Cause analysis | Chemistry | Corrective and Preventive Actions | Data review | EU regulations | FDA Regulations | ICH Guidelines | Impact Assessment | JMP | LIMS | Laboratory investigations | Management systems | Out of Specification | Out of Trend | Pharmaceutical Quality | Pharmaceutical Quality Assurance | Pharmaceutical analysis | Preventive actions | Quality Assurance | Quality Management Systems | Quality management | Risk Assessment | Root Cause Analysis | Root cause | SAS | SharePoint | Tableau | Veeva Vault
Education
Roles
Regions
Countries
States
Cities
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