Stephanie G. Email & Phone Number

• Analysis of Bioburden Excursions, Network Subject Matter Expert: Performed calculations of various proteins and toxins in order to evaluate patient safety; Presented findings to the Quality Review Board • Project Lead - Online Endotoxin Technology introduction• Project Lead - Charles River Nexus Endotoxin Robot introduction • Project Lead - Growth Promotion revamp project; Responsible for protocol authoring, study, Change Control, and Final Report• Experienced with external & internal audits• Audit technical translator (Spanish)• 2018 Intern manager- winner of best project for Nexus Robot• Initiated, compiled, and performed laboratory investigations pertaining to environmental monitoring excursions and product excursions• Experienced change record owner with ability to collaborate cross-functionally and across the network• Continuous improvement practitioner • Microbial assay tester and trainer [Bioburden, Endotoxin, Growth Promotion, Colony Counting, Gas testing, Utility sampling, Cryopreservation, etc]• Performs Safety Walks and upholds quality and safety in any activity

• Redacted and compiled Certificate of Analysis • Led Hematology and Immunoassay group and performed corresponding testing for in-process, and finished product• Performed validation testing for a variety of analytical instruments• Performed calibration, quality control testing, and troubleshooting of machinery• Performed QC analysis using Westgard rules• Performed efficiency improvements for testing groups• Performed homogeneity testing of finished product• Efficiently multi-tasked between analytical instruments

• Evaluated the quality of Class II and Class III medical devices manufactured by the company. Several techniques and critical thinking were applied to achieve the most accurate results. • Revised current SOP’s and redacted new ones.• Separated blood components, and analyzed quality markers such as: blood cell counts, pH, gases, electrolytes, plasma hemoglobin, ATP and 2,3 DPG.• Extracted biological fluids by Perchloric acid methodology.• Analyzed residual white blood cells and P-selectin with Flow Cytometer.• Analyzed hypotonic shock response and extent of shape change as quality markers in platelets.• Analyzed coagulation factors and related tests in plasma.• Enhanced and validated ELISA Test for thrombin-antithrombin complex detection.• Prepared solutions, calibrated equipment, and ran controls as part of the daily routine.• Performed statistical analysis for the precision, accuracy and linearity tests required for validations as well as Descriptive Statistics to analyze data from different studies.• Had continuous training in scientific procedures, QIP, GLPs and Bloodborne Pathogens.

• Worked on DNA isolation of in-house and international cord blood samples for a CCR5 receptor study in conjunction with City of Hope hospital• Compiled and created database of samples for in-house lab• Worked cross-departmentally with processing lab in order to coordinate result delivery and testing with National Marrow Donor Registry

Bachelor'S Degree, Microbiology, Immunology, And Molecular Genetics

Activities and Societies: The MIMG department mission is to study the interdisciplinary fields of Microbiology, Immunology and Molecular.

Professional Certificate, Project Management

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