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Quality Control Analyst
2 months ago
Reporting to the Senior Manager of Quality Control, the Quality Control Analyst, will be responsible for supporting cGMP Quality Control operations relating to testing of DNA, mRNA, gRNA, and LNP.
- Support stability evaluations and shelf-life extensions of drug substance and drug product through population of a stability database with relevant data and generation of trending charts.
- Support monitoring of analytical method performance through generation of trending templates, population of database with relevant method performance indicators, and generation of trending reports.
- Support the shipment of quality control samples and critical reagents from/to CDMOs and contract laboratories.
- Perform verification of data generated internally and externally in support of method qualification/validation, lot release, and stability activities.
- Assist in authoring and review of internal and external protocols and reports related to analytical method qualifications/validations and product stability.
- Support of cGMP operations, including generation of documentation in support of change controls, CAPAs, deviations, OOS, and other investigations or assay troubleshooting.
