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San Juan Bautista, CA, 95045
... SAP, Pointman, Agile, Intuitive, Access, Oracle, Vantive, 4D, Brio, AS400 Training: FDA Process Validation Requirements and Industry Practice Certification 2012 TCT Trans catheter Cardiovascular Therapeutics Conference San Francisco, September 2009. ...
- 2021 Mar 04
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