Summary: * 15+years of experience in instrumentation and analytical/microbiological testing. * Conducted routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy * Provided technical support and leadership as pertains to analytical/microbiological testing: verify that results are accurate and complete, recognize deviations in test procedures and/or SOPs, and appropriately document QC data and investigations * Performed testing using various instrumentation (Vitek, GC, UV, microscope, gram strainer, robotics) while adhering to cGMP and established policies * Performed routine hemostasis testing with manual and automated instrumentation (Fibro meter, MDA, MTX I, II, & III, and XM, MAX Thrombolyzer) * Investigate anomaly/excursions related to microbiological test results. * Monitor, adjust, create and validate test methods to ensure they are current and compliant with industry standards and regulations. * Train and develop technicians in microbiological techniques * Microbiological testing included water collection, filtering and bioburden, LAL (endotoxin), plate reading, growth promotions, and bacteria ID's, gram staining * Conducted routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy * Provided technical support and leadership as pertains to analytical/microbiological testing: verify that results are accurate and complete, recognize deviations in test procedures and/or SOPs, and appropriately document QC data and investigations * Microbiological testing performed on MDPI (multidose dry powder inhalers) and MDI (multidose inhalers) API and solid dose products * Perform growth promotion, microbial enumeration testing, bioburden, endotoxin testing (gel-clot method), preparing samples for outside testing * Provided technical support to analysts within both labs, review raw materials, in-process, and final batch release, revise, update, and create SOP's, Quality Audits (FDA, NSAI, Customer, ISO etc), * Harvesting cells, splitting, cells, media preparation, passaging cells and maintaining cells for testing within tissue culture lab, all assays performed to release finished goods * Cleanroom personnel trainer, Qualification and Validation of ISO certified cleanroom * Cell assays and microbial testing performed on lab ware product and IVF dishes produced at CLS * Growth promotion, bactifungi, correction factor, dose establishments for product families, microbial plate reader (Omnilog/ Biolog/Vitek), Gram staining, conduct laboratory investigations for failures of Environmental monitoring, microbial identification, cell assays * Tissue/Cell Culture Assays ie., (BHK-21, L929, EcoPak, HT1080, Vero Cells, Rat Cerebella, Panc-1, Fibronectin A-172), * Testing included GC, platelet mobility, platelet aggregation, particle sizing, platelet function (aspirin works, creatine assay) platelet mobility, particle counts, colorimetric and fluorescent assays Conductivity pH
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