Experienced supervising, critically problem solving skills essential training, and providing mentorship to groups of 05-40+ quality/production technicians across several shifts. Ample experience following and meeting tight production schedules following all regulatory guidelines from the FDA, EMA, ICH,and other international entities, experienced performing quality control activities and conducting testing in a laboratory environment and manufacturing environment, additionally, versed with a number of immunology, Biotechnology, Chemistry, Cell Culture, electrophoretic, and microbiology I/II, Applied Microbiology techniques with Labs.
Immunology: Enzyme-linked immunosorbent assays (ELISA), immunofluorescence assay (IFA), Single Radial Immunodiffusion Bioassay (SRID)
Cell Culture: Aseptic techniques, transfection / transformation, cytotoxicity Bioassay's, animal and plant tissue culture, pH meter, microscope, centrifuges, aseptic Multichannel micropipetting, welders, sealers, cell count under sterile techniques, plating, passaging, cellular incubation, re-cultured established cancer cell lines, freezing cells, media / reagent preparation, dilution factors.
Electrophoretic: SDS polyacrylamide gel electrophoresis (SDS-PAGE), Western blot, Southern hybridization).
Chemistry: Wet Labs, Prepared chemicals and agars/medium for undergraduate labs; Immunology and Cell culture groups of students.
Using autoclave to dispose of biohazard material, as well as sterilize media and glassware. Extensive training in laboratory BSL-1, BSL-2, BSL-3.
Microbiology: Streak to isolate, gram stain, cultures of different organisms Independently monitored, collected, evaluated and reported all data on routine & non-routine environmental monitoring, gram staining, spore, and preparation of buffers, media, pour plates, plating antibiotic-sensitivity testing, Worked with Mac Conkey's, Tryptic Soy Agar, Mannitol Salt Agar,Blood Agar, aseptically prep/pour media and recorded all data pertaining to incubation time and results.
Compliance: Change Controls, Control documents, Log books, change control, Resolutions of Out of Specification (OOS) ,and Corrective actions and preventive actions (CAPA).
Computer: Microsoft Word, Excel, PowerPoint, Trackwise. SAP, SOP, LIMS, Clinical Laboratory Instrument plus calibrations, IMMUlab, SCORE, Electronic Batch Records (EBR), Master Data in Manufacturing Execution System (MES) and Distributed Control System (DCS),
Languages: Bilingual ( main English - secondary Spanish)
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