Analytical Services Scientist
Tasks
- Administer quality computer systems and perform periodic review
- Author standard operating procedures and work instructions
- Conduct laboratory investigations
- Coordinate validation of laboratory equipment and software
- Develop and validate analytical methods
- Generate and approve validation plans protocols and final reports
- Lead root cause analysis and determine CAPA plans
- Maintain investigation metrics and quality council metrics
- Manage calibration maintenance and outside service coordination
- Manage change control for laboratory systems
- Manage laboratory waste handling labeling and disposal
- Perform performance qualification and system life cycle documentation
- Provide analytical technology expertise for quality control
- Transfer and verify analytical methods
- Troubleshoot methods and instruments
- Write protocols for instrument introduction and qualification activities
Perks/Benefits
- N/A
Skills/Tech-stack
Automatic Titrator | CAPA | CDMS | CGMP | CSV | Cause analysis | Change Control | Chromatography Data Systems | Commissioning | Computer system | Computer system validation | Corrective Action | Corrective Action Preventive Action | Data Analysis | Data Systems | Dissolution testing | Empower | FDA Regulations | FMEA | FTIR | Failure Mode and Effects Analysis | GAMP | GC | HPLC | IQ/OQ | IQ/OQ/PQ | Instrument Calibration | KF | LIMS | Laboratory investigations | Labware | MS Office | MS Project | Method Development | Method transfer | Method validation | Method verification | NIR | OQ PQ | Performance Qualification | Preventive Action | Qualification | Root Cause Analysis | Root cause | System life cycle | System validation | TOC | UPLC | UV Spectrophotometer | Validation | Vantage
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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