High-performing Senior QC Associate with method validation and presentation skills. A quick learner know for excellent problem solving skills with the ability to communicate complex technical information. Experience developing detail and intricate training tools to convey and simplify scientific concepts using Excel, Movie Maker, Powerpoint and other proprietary software programs.
Recipient of Full Trustee Scholarship, given to Top 1% of entering freshmen class
Maximized lab efficiency by expeditiously becoming acclimated to all clinical testing and cross-trained peers and superiors to ensure that all training is completed and current for all commercial assays and Oracle/ERP, as well as LIMS before Dendreon's 2011 commercial launch.
Prepared and presented presentations for flow cytometry, ELISA, Endotoxin, and Gram Stain to effectively reduce analyst errors directly related to those assays.
Delegated to familiarize management and train all associates and transfer the hybridoma in vitro cell culture/ELISA to Dendreon's European contract laboratory prior to the 2014 EU launch; subsequently facilitated a successful stability study prior to the EU launch in the Netherlands, EU.
Mastered intricacies of QC laboratory including release testing and documenting of OOS and Deviations. Obtained certification to become a trainer to junior associates by writing detailed training plans for Flow Cytometry, Gram Stain, CBC, Viability, Endotoxin, and ELISA. Selected to interview and screen prospective QC staff. ◦
Effectively perform analysis of non-routine and in-process materials, finished goods and stability samples within established timelines. Ensured all testing and documentation met cGMP requirements. Captured all data in StarLIMS. ◦ Certified to operate analytical instrumentation including: HPLC, Spectrophotometer, pH Meter, and Osmometer.
Perform and train all on in-site testing of in-process, release, and stability biopharmaceutical samples including: pH, purity, and protein determination. Drafted and performed Validation Protocols and Validation Reports for Quality Control test methods developed on site. Calibrated, trouble-shot, and maintained laboratory instrumentation including HPLCs, UV/Vis, MWD, DAD, ELSDs, Spectrophotometers, Osmometer, and Particulate Matter Analyzer for optimal performance. ◦ Minimized deviations by drafting and revising Standard Operating Procedures for analytical instrumentation and analytical test methods. ◦ Delegated to operate as interim stability coordinator.
Quality Control, Wet Chemistry, cGMP and GLP Documentation, Analytical Instrumentation, CBC, Elisa, Raw Material Release Testing, Flow Cytometry, Procuct Inspection, LIMS, Process Development, IQ/OQ/PQ Validation, Method Transfer, Product Release Testing, Analytical Test Methods Creation/Revision, Troubleshooter, UV/vis, Validation Protocols Drafting and Executing, HPLC, Instrument Calibrating, FTIR, Spectrophotometer, Equipment Sales, Laboratory Equipment, Revise and Draft SOPs, Waste Collection/Removal, Data Collection/Trending, Oracle, Group Training.
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