- Quality Assurance review and approval of analytical data for release of CGMP manufacturing batches (UPLC, HPLC, IC, etc)
- Review of instrument audit trails for compliance
- Quality Assurance review and approval of analytical method protocols, validations and reports (UPLC, HPLC, IC, etc)
- Creation of CoAs for analytical testing
- Review and approval of analytical change controls and deviations and CAPAs
- Perform internal facility and quality system audits.
- Assist with SOP revisions and writing new SOPs.
- Other duties as requested by the Quality Management.