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)

• 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

• 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.

• 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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