Senior Analyst, Quality Control Sample Control (Friday to Monday) FUJIFILM Biotechnologies USA Inc
Senior Analyst, Quality Control Sample Control (Friday to Monday)Will handle temperature excursion alerts to client if necessary Documents receipt, storage, and movement by making entries into Labware LIMS and/or internal sample chain of custody forms or logbooks Collaborates cross-functionally to address issues that arise from manufacturing, laboratories, or the warehouse Authors and reviews SOPs, protocols, reports, change management reports, CAPAs and Trackwise deviations related to Sample Management and Stability Studies Creates CoA's and result summary reports to support batch disposition Participates in continuous improvement projects and SOP revisions by contributing input to the process, and supports associated procedural updates Ensures sample integrity in all aspects of working with samples and reference materials Assist in training new analysts, as needed Performs other duties, as assigned Requirements: Excellent attention to detail. Executes sample reconciliation to ensure all samples were collected as per approved LIMS plan or protocol Maintains and supports equipment alarms during off hours and move samples, as required Executes movement of QC samples from Manufacturing to the QC labs and maintains sample chain of custody and GMP documentation Serves as advisor for program management by overseeing Stability Sample Sets, proper storage conditions and pulling samples per approved protocols and internal procedures to ensure proper management of all on-going studies in accordance with ICH guidelines and client requirements Receives, inspects, and inventories reference materials and samples from external sources.
