Engineer Technical Support

R I K A A I Z A W A

**** ******* ***** #** *** Angeles, CA 90065 510-***-**** Email: **********@*******.***

Q U A L I F I C A T I O N S :

Biotech/Pharmaceutical professional with Quality Assurance, compliance, scientific laboratory and information technology background, having over 8 years of experience including Pharmaceutical and Commercial Software industries. Possesses strong analytical and problem solving skills with detailed knowledge of software validation, quality assurance and compliance process for regulated environments. Also possesses essential knowledge and learning skill in laboratory analytical instruments and biochemistry laboratory techniques. Background in technical support and experienced corporate trainer with ability to deliver course materials in a multi-lingual environment.

Installation, validation and customer support for a web based laboratory data management software, IQOQ. IT, Networking, Support.

Microsoft Office, Microsoft OS, Client & Server Administration, IE, Chrom, MacOS, SQL/Oracle Databases, VMWare, Symantec Ghost Cast. Grey and Blackbox Testing, SDLC, test tracking matrices, SixSigma White belt.

Drafting and writing Standerd Operating Procedure, (SOP), qaulity and compliance

Bilingual Japanese/English, familiar with Spanish.

P R O F E S S I O N A L E X P E R I E N C E

Barista/Retail

Blue Bottle Coffee Company, Los Angeles, CA

June 2015-Present

Crafting coffee beverages at a speciality coffee company. Emphasis on crafting of delicious beverages, and customer experiences

2011 Thru 2015 Sabbatical Leave

Technical Writer/System Validation Engineer

Biosense Webster (Johnson and Johnson) Los Angeles, CA

August 2011 – October 2011 (A temporary assignment with Kaztronix)

Supported a data migration project. Duties including, redlining controlled documents, performing User Acceptance Tests, and verifying migration data.

Technical Writer/System Validation Engineer

PSC Biotech at Neutrogena, Los Angeles, CA

May 2010 – December 2010 (Contractor)

Supported Neutrogena’s compliance project by transcribing validation data and contributing to other GMP documentation, including Standard Operating Procedures (SOPs), Change Control documents, and Good Manufacturing Practices (GMP) training materials.

Gap analysis for validation of VITEK 2Compact 30 System.

Design Validation Engineer

Novartis Diagnostics Inc., Emeryville, CA

August 2009 - October 2009 (A temporary Assignment with PROUnlimited)

Developed test cases/plans system, instrument and software validation of HIV/HCV/HBV blood testing assay.

Developed SOPs.

Quality Assurance Engineer/System Analyst

Agilent Technologies Inc./Scientific Software Inc., Santa Clara, CA

September 2001 – August 2009

Validated web based laboratory data management, and Control /Analysis software (OpenLAB, ECMS and EZChrom Elite) for Pharmaceutical /Biotech/Petrochemical industries.

Performed installation, training and Installation Qualification/Operation Qualification (IQOQ) of a web based laboratory data base management software at customer sites.

Managed QA projects as a lead tester based on project life cycle; developed and managed test matrices, validation plans, test cases, time and resource estimation, incidents, test result reviewing and creating product CDs and Escrow CDs.

Managed quality assurance validation for hotfix (customer raised issues) projects. Tasks included were; risk assessment, incident filing, conducting and participating cross-functional team meetings, escalation, writing test cases and validation documents.

Provided technical support and performed troubleshooting and investigation to customer raised issues.

Working knowledge on Windows NT domain and Active directory environment, as well as virtual machines (VMWare).

Conducted corporate trainings in Japan. Provided language translations for software, and training materials, provided customer/technical support and performed user acceptance tests.

Black box testing on software written in VB, C++, and using .NET Framework.

Worked closely with engineering during Research and Development phase.

Working knowledge in software/system development life-cycle, agile software development methodology, iterative development in cross-functional teams.

Translator

PSCBiotech, Pomona,,CA

March 2005 (Contactor at PSCBiotech)

English to Japanese translation for User Interface menu, messages for TrackWise.

Formulation Development Research Associate

Elan Pharmaceutical Inc., South San Francisco, CA

March 2001 - July 2001 (A temporary assignment with Spherion)

Performed buffer formulation protein stability analysis on HP1100 in a cGMP regulated laboratory.

Performed instrument maintenance and calibration.

Production Technical Associate

Bio-Rad Laboratories Inc., Hercules, CA

August 2000 - February 2001(A temporary assignment with Kelly Scientific)

Performed production of HPLC resin following SOPs in a cGMP regulated manufacturing laboratory.

E D U C A T I O N

BACHELOR OF SCIENCE IN BIOCHEMISTRY, MOLECULAR BIOLOGY, December 1999

University of California, Santa Barbara. Santa Barbara, CA

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