Grace Cruz Email and Phone Number

I am Quality Professional with broad experience in a variety of biochemical and analytical assays.In 2004, I started working as a Biochemistry Associate performing stability, in-process, and final product testing for a commercial drug product in a GMP-regulated environment.In 2007, I joined the Protein Therapeutics group within DMPK at Roche Palo Alto. I was involved in Bioanalytical Method Validation, assay transfer, and Preclinical testing of samples using ELISA, under GLP and non-GLP operations. I was also heavily involved with CRO management functions where I interfaced with CROs to address technical assay issues and ensure continuation and compliance of on-going large molecule projects.In 2010, I worked as a QC Scientist at NuGEN Technologies in San Carlos, CA. In this role, I performed QC Testing of our genomic sample preparation kits. In addition to routine testing, I was also involved in various investigation and troubleshooting experiments, process improvement projects, internal auditing of our quality system, as well as participated in audit teams for our company's ISO 13485 surveillance and re-certification audits.In 2015, I worked as an associate in the Quality Control (QC) analytical chemistry laboratory, perfoming routine release, stability, and raw material testing. As a QC Associate, I was involved with investigation and troubleshooting experiments. I was also the Training Line Unit Administrator for the Quality Control group. Since 2017, I have been working in Quality Assurance for Boehringer-Ingelheim. As QA Specialist for the Drug Product Disposition group, I am the main QA contact for QC oversight.Technical Skills: Preclinical Immunoassay Transfer and Method Validation, CRO Management, Assay Troubleshooting, Microbiology testing, LAL, TOC, ELISA, Size Exclusion Chromatography, Bioburden, Aseptic Technique, GLP, GMP, Microarray, qPCR, Bioanalyzer, Karl Fisher, RP-HPLC, Aerosol Testing, Deviation and Change Management, Quality Oversight