Scientist II, QC Analytical (2nd Shift)
Tasks
- Author and review QC reports and SOPs
- Compile analyze and interpret assay data
- Develop optimize and validate analytical methods
- Draft and revise assay methods sampling plans and process documents
- Drive completion of laboratory training
- Implement corrective and preventative actions
- Investigate OOS results and determine root cause
- Lead and perform analytical testing assays
- Perform in-process, release, and stability testing
- Perform review and approval of laboratory data and investigations
- Provide technical guidance and mentorship
- Review and approve GMP documentation and analytical methods
- Support deviations change controls and CAPAs
- Support regulatory and client inspections and internal GMP audits
- Track and trend testing data and lead OOS OOT investigations
- Transfer analytical methods to quality control
- Troubleshoot analytical methods and processes
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Method Development | Analytical method validation | Biochemistry | CAPA | CGMP | Cause analysis | Cell biology | Change Control | Corrective And Preventative Actions | Data Analysis | Data Interpretation | Deviations | ELISA | EQMS | GMP documentation | HPLC | LIMS | Method Development | Method validation | Molecular Biology | Molecular biology assays | Nucleic Acid Assays | OOS Investigation | Preventative actions | Protein assays | QPCR | Root Cause Analysis | Root cause | SDS-PAGE | Troubleshooting | Western blot
Education
Roles
QC Scientist | Quality Control Scientist | Scientist | Scientist II
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