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Morgan Hill, CA
... WellDoc-BlueStar®, 2014 Creating High-fidelity prototype to use by FDA for the second generation of BlueStar® application. WellDoc began commercializing BlueStar® for adults with type 2 diabetes in 2014. BlueStar is the first mobile prescription ...
- 2020 Jun 30
San Jose, CA, 95136
... Prepared an application for FDA submission. This included: creating and running the necessary test cases, generating the traceability matrix between product requirements, engineering requirements and test cases, risk analysis from the engineering ...
- 2019 Apr 25
Gilroy, CA
... Logistics Functions: Perform contract negotiations, contract management, international vendor and customer relations resulting in an average 15% cost savings to the customer with FDA rendering in less than 30 days. Actively managed over 100 ...
- 2019 Apr 11
Hollister, CA
... Responsible for long-term planning of resources, capital, and projects for semi-annual maintenance shutdowns, as well as project planning and implementation for an FDA regulated parental drug manufacturing facility. Responsible for spearheading and ...
- 2018 Dec 13
Gilroy, CA
... Instructional Designer 2011 -2018 Instructional Designer 2007-2011 Abbott Laboratories Morgan Hill, CA Technical Training Developer 2004-2007 Training Specialist 2002-2004 Designed learning programs that are in compliance to FDA (Food & Drug ...
- 2018 Sep 13
Morgan Hill, CA
... - Designed screening experiments to discover polymorphs and developed crystallization processes in compliance with FDA regulations to meet development objectives leading to successful, timely delivery of 4 projects - Characterized materials ...
- 2018 Aug 30
San Jose, CA, 95123
... development and validation Assist management in preparation of internal customer and agency audits Standards: GMP, GLP, GCP, US-FDA, CFR21, ISO, WHO, IND, NDA, ANDA, CDER, DMF, eCTD, ICH, CAPA, IP, USP, EP Skills: Analytical: HPLC, GC, LC/MS, GC/MS, ...
- 2018 Jun 15
Morgan Hill, CA
... Located, audited, and certified supply chains, which are FDA 13485 & 21 CFR Part 11, Conflict Materials, and RoHS Compliant for Product Development Roadmap. Provided technical, Lean Sigma, and Business Support for cross -functional teams for Value ...
- 2017 Sep 08
Morgan Hill, CA
... auditor - CAPA, MRB, FRB, FMECA, 8D, 5’s, knowledge - Machine shop knowledge and experience - Semiconductor experience, PCB, breadboard troubleshooting - SPC, Six Sigma, Root cause analysis experience - FDA, QMS, TQM Compliance experience. ...
- 2017 Apr 17
Morgan Hill, CA
... in several 6 Sigma Project both Green and Yellow Belt Participated in both preparing for ISO 90001, ISO 13485 and FDA audits Experience with both SAP and MFG Pro ERP systems Professional Experience Abbott Laboratories, Milpitas, California ...
- 2017 Feb 21