Experienced Supervisor Aseptic Biologic, using critically thinking for problem solving is essential for training, and providing mentorship to groups of 05-40+ employees in quality/assurance/production technicians across several shifts. Efficient experience following and meeting tight quality and production schedules following all regulatory guidelines from the FDA, EMA, ICH and other international entities. Demonstrated documentation management skills, ability to design and implement quality processes.
Immunology: Enzyme-linked immunosorbent assays (ELISA), immunofluorescence assay (IFA), Single Radial Immunodiffusion Bioassay (SRID)
Cell Culture: Aseptic techniques, Bioassay's, animal/ plant tissue culture, pH meter centrifuges, aseptic multichannel micro-pipetting, and cellular incubation.
Electrophoretic: sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), Western blot.
Chemistry: Wet labs, Using autoclave to dispose of biohazard material, as well as extensive certifications in laboratory BSL-1, BSL-2, BSL-3.
Microbiology: Streak to isolate, gram stain, cultures of different organisms Independently monitored, collected, evaluated and recorded all data pertaining to FDA regulations protocols.
Compliance: Change Controls, Controlled SOP, RAW documents, Log books, work sheet, Resolutions of Out of Specification (OOS), Corrective actions and preventive actions (CAPA), leadership through usage of Performance Improvement Plan (PIP).
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)
Bayer's Awards: Leadership, Efficiency, Management
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