QC Analyst I - Rockville, MD
2 weeks ago
Perform inspection sampling testing of incoming raw materials according to internal specifications procedures drawings other applicable controlled documents per schedule within established turn-around times Collaborate with Materials Management to receive prepare shipments of raw material samples lot release samples stability samples for testing performed by contract laboratories Follow established procedures perform tasks in accordance with cGMP requirements Prepare composite samples aliquots using aseptic technique in ISO areas biological safety cabinets May perform routine analytical testing including more complex methods cell culture growth promotion basic methods concentration by UV absorbance pH conductivity appearance osmolality draeger tube gas testing Raman IR environmental monitoring in accordance all protocols procedures Perform physical inspections stored materials maintain accurate tracing tracking Quality Control sample retain inventory Record data LIMS SAP ensuring completeness accuracy cGMP Compile review data ensuring data integrity adherence SOPs Ensure data storage archiving performed per established procedures Maintain sampling room constant state cleanliness compliance inspection readiness ensure sampling room sample packaging inventory stocked required cleaning solutions sample containers labels etc Order materials via SAP Report discrepancies nonconforming materials management support subsequent investigations other Quality event records e.g Deviations CAPAs electronic document management system MasterControl coordinate appropriate departments issues concerns Prepare general lab solutions buffers needed monitor expiration these solutions buffers Perform duties assigned
Job description
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