Scientist II, QC Analytical (2nd Shift)
Tasks
- Analyze and interpret assay data
- Author and review QC reports SOPs protocols and specifications
- Develop optimize and validate analytical methods
- Draft and revise assay methods and sampling plans
- Ensure training completion for direct reports
- Investigate OOS and nonconforming results
- Lead and perform analytical testing assays
- Perform in-process, release, and stability testing
- Provide technical guidance and mentorship
- Review and approve GMP documentation
- Review and approve laboratory data and methods
- Support deviations change controls and CAPAs
- Support internal GMP audits
- Support regulatory and client inspections
- Track and trend testing data and lead laboratory investigations
- Transfer analytical methods to quality control
- Troubleshoot processes and assays
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Assay | Analytical assay development | Assay Development | Biochemistry | CAPA | CGMP | Cause analysis | Cell biology | Data Analysis | Data Interpretation | ELISA | EQMS | HPLC | LIMS | Laboratory investigations | Method validation | Molecular Biology | OOS Investigations | QPCR | Root Cause Analysis | Root cause | SDS-PAGE | SOP Authoring | Troubleshooting | Western blot
Education
Roles
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