Quality Assurance Control

Education University of California at Irvine, Irvine, CA

Sept 1995 - Jun 2000

( BS Applied Ecology; Coursework: Chemistry/Biology

Santa Clara University, Santa Clara, CA

Sept 2007 - Dec 2009

( MBA

Experience Allergan Medical, Santa Barbara, CA

Aug 2010- present

Senior Supplier Quality Specialist

( Evaluate and monitor external suppliers to ensure they meet

company requirements and comply with

applicable international standards, regulatory and quality

system requirements.

( Provide supplier quality support to product development and/or

other supplier-related projects.

( Create, compile and organize documentation.

( Direct supplier approval, and certification activities.

( Maintain the Approved Supplier List.

Abaxis Inc, Union City, CA Oct

2005- July 2010

Quality Assurance Engineer

( Organized validation of software release on multiple product

lines

- Managed 2-5 person teams along with resources from

departments in operations, technical support, document

control and research and development

- Authored/developed GUI, instrument communication,

chemistry algorithm and production compatibility

validations from scratch

( Led project teams to qualify and release new OEM product.

- Coordinated with Shipping/Receiving, Business Development

and Instrument Repair to implement new procedures, test

materials and met product release deadlines.

( Performed complaint investigations

- Generated trend tracking and field failure reports for

management presentations

- Provided statistical data and analysis to technical

service representatives for product feedback and

maintenance of customer satisfaction

( Developed new SOPs including extended testing of

instruments, complaint handling,

return material authorization modifications and final

inspection procedures.

- Facilitated timely root cause analysis and investigation

closures

- Implemented repair evaluation procedure which eliminated

"repeat offender" repairs saving approximately $500/failed

repair instruments

- Shifted preventative maintenance responsibilities away

from the Instrument Repair Department, considerably

reducing repair backlogs

( Trained new personnel in assembly process

- Reduced by 12% instrument failures outgoing to customers

Abaxis Inc, Union City, CA

Feb 2004 - Oct 2005

Quality Control Chemist

( Performed functional, stability and calibration studies of

production lots

- Streamlined study test procedures, eliminating incorrect

instruments usage and missed study dates

( Performed chemical purity tests to incoming reagents and

confirmed raw material integrity

- Maintained chemical inventory for use in formulation

process

- Maintained timely release of control material for

hematology products

Iconix Pharmaceutical, Mountain View, CA

Nov 2000 - Dec 2002

Research Assistant

( Hybridization Module-Team Lead:

- Streamlined SOPs to improve pass rates and output quality

- Trained new team members in the manufacturing process

- Represented team in meetings establishing quarterly/weekly

goals, determining project timelines and updating progress

on continuing projects.

- Collaborated with Informatics group in troubleshooting

failed sample output and various errors types

( Target Preparation Module:

- Trained new team members in the operation of automated high

throughput

- Worked with vendor representatives in troubleshooting

automated system problems

- Improved yield recovery in cRNA synthesis and target

preparation

Qualifications

( Six Sigma Green Belt

( Microsoft Word, Excel, Access and PowerPoint proficient

( Minitab, JMP and SAP experience

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