Description
Requirements:Open/close production lines for reagent and carrier box packing and releasePrepare and print DHR checklists, label bead library bindersEnsure Deviations and NCMRs associated with DHRs are approvedReview and closure of NMCR material verification phase (disposition of scrapping material and ERP adjustment)Control and issuance of stability samples QC testingCoordination, inspection and release of liquid Nitrogen deliveriesReview and filing of equipment calibration, maintenance, and repair recordsReview and filing of temperature monitoring chartsReview and filing of Daily Equipment ChecklistsApplication of released material status labelingQUALIFICATIONS:Bachelor's degree within scientific disciplineWorking knowledge of 21 CFR 820 and ISO 13485Approximately 3-5 years previous experience in QA/QC role in the medical device/in vitro pharmaceutical environment