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FDA resumes in Pleasant Hill, CA

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Alliance Manager Research Associate

Martinez, CA
... protocols and reports to execute and close out studies Designed, planned, and executed studies based on requirements from the FDA for assay approval Analyzed data via in-house analysis tools and programs and perform statistical analyses of data Head ... - 2021 Oct 06

Plant Manager Hayward

Alameda, CA
... Prepare documentation for review by US Food and Drug Administration (FDA) and other agencies. Perform quality control and documentation reviews for all devices produced by 50-person team. Train new employees on microscopic assembly and laboratory ... - 2021 Sep 21

Sponsor Project Manager

San Francisco, CA
... Clinical Trials Associate ● Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.). ● Sets-up and maintains the Trial Master File (TMF) using Veeva system. ● ... - 2021 Jul 28

Purchasing Agent/Buyer

Oakland, CA
... projects and initiatives to improve systems, processes and overall delivery of procurement services • Ensured compliance with FDA, cGMP and IS09000 • Procured large capital equipment, radioactive materials and services • Provided procurement support ... - 2021 Jun 24

Pharmacy Technician Quality

Oakland, CA
... Participated in audit performed by internal and external representative for FDA compliance. Participated working with the project terms and providing research and advice on compliance with federal laws and FDA/USDA guidelines Order the routine ... - 2021 Mar 04

QA QUALITY SYSTEMS

Castro Valley, CA
... Supported inspection readiness and performed as Librarian for 2 successful inspections (FDA and IMB). Associate, Quality Assurance May 2008 – April 2009 (Formerly: CV Therapeutics, Inc.) Implemented and maintained Document Control metrics. ... - 2021 Feb 06

Lean Six Mechanical Engineer

Walnut Creek, CA
... Highly skilled in creating Test Methods, Test Protocols, and writing technical reports as FDA regulations. Experienced in Continuous Improvements (CI), CAPAs, cGMP, and GDP regulations, statistical process control (SPC), MSA, DOE, IQC and, Lean Six ... - 2020 Dec 10

Engineer Quality

Livermore, CA
... Process Controls, Validation and Project Management professional with extensive experience of regulations cGMP, GxP, FDA, ICH, EU, ISO and 21 CFR 11, 820 related to Pharmaceuticals, Biotechnology, Medical Devices and Computerized Systems. ... - 2020 Nov 13

Mechanical Engineer

Vallejo, CA
... as communications lead with a team of colleagues, faculty, and sponsors to create the electro- mechanical machine that uses FDA-approved components • Utilized sub-assemblies in SolidWorks to stage major processes of root-grating automation • ... - 2020 Sep 10

Biomedical Engineering

Hayward, CA
... • The chosen device for this mock document was the Neuroform Atlas Stent System as approved by the FDA. Device Design Project, San Jose State University August 2016 – December 2016 • Created a hand-drawn blueprint and written documentation of a ... - 2020 Aug 30
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