Scientist I, QC Analytical
Tasks
- Analyze and interpret assay results
- Author and review SOPs
- Author and review analytical methods and forms
- Conduct ELISA testing
- Conduct compendial testing
- Conduct viability testing
- Drive analytical method development and optimization
- Execute analytical method testing
- Implement CAPA actions
- Investigate OOS results
- Maintain assay data records and archiving
- Perform method qualification and method validation
- Provide mentorship to junior team members
- Review and approve GMP documentation
- Support deviations and change controls
- Support internal GMP audits
- Support regulatory inspections
- Track and trend testing data and OOS OOT investigations
- Troubleshoot assays
- Write and review validation protocols
Perks/Benefits
- 401k match
- Employee assistance program
- Employee discounts
- Health, dental, vision insurance
- Long-Term Disability coverage
- Mentorship programs
- Onsite fitness facility
- Paid time off
- Parental leave
- Professional development resources
- Short term disability coverage
Skills/Tech-stack
AUC | Analytical method qualification | Analytical method validation | CE | CGMP | Cause analysis | Change Control | Compendial testing | Corrective And Preventative Actions | Data Analysis | Data Interpretation | DdPCR | Deviation Management | ELISA | EQMS | GMP documentation | LIMS | Method qualification | Method validation | OOS Investigations | Potency assays | Preventative actions | QPCR | Root Cause Analysis | Root cause | TCID50 | Troubleshooting | Viability Assays
Education
Roles
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