GMP Data Reviewer

Water SystemsGMP review of microbiological testing of the facility and/or laboratory water purification system samples. Tests included are LAL and Bioburden.GMP review of analytical testing of the facility and/or laboratory water purification system samples. Tests included are TOC, Conductivity, EU WFI Chemical Testing.GMP review of Qualification and Media Release testing.GMP review of facility cleaning data and in-processing testing, including but not limited to endotoxin, bioburden, BI, HPLC, Protien Concentration, pH and Osmolality.Initiation and follow-up of exceeded alert and action limits per procedures.Participate in preparation of quarterly trending reports​Raw MaterialsGMP review of general appearance/identifications and FTIRGMP review of house gas/air sampling and testingInitiation and follow-up of OOS and action limits per procedureElectronic and physical receipt, log-in and distribution of samples and testings materials coming into QC.Discarding / completing sample custody chainPreparation and shipping of sample/materialsAliquoting of bulk samples, assay standards, assay controls and custom assay reagentsLaboratory SupportAssist in updating and writing SOP'sRoutine calibration and maintenance of laboratory equipment which includes pipettes, balances, plate readers and pH metersCleaning of incubators, laminar flow hoods and biosafety cabinetsCleaning of refrigerators and cold roomsDefrosting of freezersDisinfectant preparationMaintenance of solvent wash bottlesCleaning of water bathsGMP lab sweepsEquipment out-of-tolerance (OOT) and refrigerator, freezer, incubator and pipette investigationsWeekly distributed control system (DCS) documentation review and maintenanceParticipate as required in any investigations associated with their deliverables supporting this task order