Quality Control Process

MARY T. NGUYEN

**** ***** **** **. *** Jose, CA *5121

Tel: (408) 472 – 2350/E-mail: ************@*****.***

OBJECTIVE To obtain the Process Development Engineer position to develop, improve, direct, and execute

projects for new technology, products, materials, processes, or equipment development.

SUMMARY

+16 years in diagnostic medical device

Highly dedicated, self-motivated, and energetic attitude

Decisive, action-oriented, results-focused, resourceful, and practical participative Quality Control,

Engineering and Program Management professional Motivated by new challenges

Ability to work well within an ever evolving, team-based environment, wherein flexibility, strong

organizational and administrative skills and attention to detail are essential attributes

Ability to lead and influence peers, cross-functional partners, management, and executive management

EDUCATION SAN JOSE STATE UNIVERSITY--Master Public Health

Emphasis: Community Health Education

UNIVERSITY OF CALIFORNIA, BERKELEY-- B.A. Molecular Cell Biology

Major Emphasis: Cell Physiology & Minor Emphasis: Ethnic Studies

DEANZA COLLEGE, CUPERTINO, CA

Certificate of Business Management

Certificate of Supervision and Management

AWARDS ABBOTT DIAGNOSTIC DIVISION Site award (1999, 2000, 2001)

COMPUTER IBM-PC and MAC knowledgeable--ClarisWorks, Harvard Graphics, Microsoft Access,

SKILLS Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Project, Information Database,

Word Perfect, and Typing Speed: +70 wpm

SKILLS Experience using Gilford, HPLC, IR, TLC, Titration, Cell Dyn, etc instruments.

Coordinate R & D, production and manufacturing process of various medical, diagnostic products

through Planning, organizing, and training for Quality Control release process

Performed Engineering Change Order and document changes for process and procedures including

SOPs, DOPs, SWIs, etc,

Review, approved, and change manufacturing procedures to conform with quality requirements and

implement CAPAs

Management and Supervision Experience for Hematology Control and Calibrator Assay testing, Assay

assignment, Quality Control Departmental tasks and responsibilities

Perform Product validation, Template Validation, and Material Qualification

Develop Stability and Retention programs

Management programs and projects including Controls, materials obsolescence, materials qualification,

process improvements/changes, DOE, product failure investigation, etc.

Strong computer (MS OFFICE, JMP) and statistical Analytical knowledge

Strong verbal and written skills

Green Belt in Process Excellence

EXPERIENCE & ACCOMPLISHMENTS

04/06- present SR. PROCESS ENGINEER PROGRAM MANAGER

Process/Materials Engineering Department

Cholestech Corp. Hayward, CA

Manage, execute, and transfer multiple Company Strategic Initiatives including Controls Program,

Materials Obsolescences, Materials Qualification, Process Improvements, CRMLN certification, LSP

certification, and CAPAs.

Review and approve all relevant Engineering and procedure changes

SIGNIFICANT ACCOMPLISHMENTS:

Support the launch hsCRP controls, hsCRP calibration, and many new critical materials within

short time

Support company to boost employees and staff morale effectively.

MARY T. NGUYEN

08/04- 04/06 QUALITY CONTROL MANAGER:

Quality Control Department

Cholestech Corp. Hayward, CA

Managed failure investigation, Material Review Board(MRB) activities, and chaired MRB meetings.

Ensure a smooth transition for all new products from R&D to Manufacturing (Ex. hsCRP cassettes,

ALT/AST Cassettes, and Controls).

Managed and coordinate group to cope with fast pace and heavy work load

Supported business to ensure all products to be released in a timely manner

SIGNIFICANT ACCOMPLISHMENTS

Develop and launch Retains, stability, new products, controls and calvers range assignment processes.

Create and develop staff for the next level

Support company to boost employees and staff morale effectively.

10/03- 07/04 QUALITY CONTROL MANAGER:

Quality Control Department

Third Wave Technologies, Madison WI

Write Engineering protocol to change process, to understand test method variability, to collect data

baseline for viable and non-viable particles of Environmental Monitoring

Manage and perform Process improvement including streamlined product monitoring and product

releasal process

Ensure a smooth transition for all new products from R&D to Manufacturing by organizing and planning

for Quality Control Testing

Perform continuous process improvements, apply compliance standards, execute CAPAs and implement

CAPAs

Manage and develop Validation program and stability program

Develop and maintain Quality Control Laboratory for QSR/ISO compliance

Manage and coordinate group to cope with fast pace and heavy work load

Support business to ensure all products to be released in a timely manner

SIGNIFICANT ACCOMPLISHMENTS

Developed Retains, stability, and new products processes.

Changed dept processes and procedures as process improvements

11/02- 08/03 TECHNICAL PRODUCT DEVELOPMENT SCIENTIST:

Reference and Quality Control Laboratories Department

Abbott Diagnostic Division, Santa Clara CA

Wrote Engineering protocol to change manufacturing process to improve product performance, increase

customer satisfaction, and reduce cost

Wrote Engineering protocol to reduce uncertainty testing and to gain additional knowledge of current

manufacturing process

Performed PICAR, Level III Investigations, and Severity Assessment Process

Ensured a smooth transition for all new product(s) and new software(s) from R&D to Manufacturing and

internal customers

Troubleshoot and resolved all Control and Calibrator Issues from internal customers as well as external

customers

Performed continuous process improvements and implement CAPAs

Assessed and changed specification using Standard Process Control

SIGNIFICANT ACCOMPLISHMENT: Successfully investigate, troubleshoot, and resolve a reagent field

issue within a timely manner.

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MARY T. NGUYEN

02/99- 11/02 REFERENCE/QC LAB SUPERVISOR:

Reference and Quality Control Laboratories Department

Abbott Diagnostic Division, Santa Clara CA

Ensured a smooth transition for all new product(s) and new software(s) from R&D to Manufacturing and

internal customers

Troubleshoot and resolve all Control and Calibrator Issues and complaints from internal customers as

well as external customers

Performed Validations, PICAR, Level III Investigations, and Severity Assessment Process

Coordinated Hematology Control and Calibrator Assay testing and Assay value assignment

Perform many process improvements including: Wrote and approved protocol for manufacturing process,

and assessed, reviewed, and proposed department processes and specification.

Developed and execute a cross training program

Manage and coordinate group to cope with fast pace and heavy work load

Support business to ensure all products to be released in a timely manner

All duties perform with ISO 9002 and cGMP

SIGNIFICANT ACCOMPLISHMENTS

Crossed train the areas to reduce cycle time

Consolidate the QC process to increase understanding and uniformity with the dept. process.

Supported a Filed Action investigation and perform specification change within 1 month

Develop a range assignment process for Controls and calvers using trending data.

Develop and promote a Quality Control technician and Scientist.

02/97 – 02/99 CHEMIST:

Manufacturing Department

Dade Behring, Inc. Cupertino, CA

Performed multiple organic drug assays using UV/Spectro instruments

Created tracking and trending database for products

Supported validation for the lyophylization process

Supported group at all time to allow group to meet business needs and deadlines

All duties perform with ISO 9002 and cGMP

SIGNIFICANT ACCOMPLISHMENT: Support Team leader to maintain Dept Morale and Sr. Chemist to

create trending database.

08/94 -03/95 QUALITY CONTROL ASSOCIATE:

Quality Control Department

Matrix Pharmaceutical, Menlo Park, CA

Performed and maintained Environmental monitoring program and generated reports

Performed in microbial isolation, identification, and bio-burden.

Worked in various aseptic manufacturing environments

SIGNIFICANT ACCOMPLISHMENT: Update procedures to streamline the process.

01/94 - 08/94 RESEARCH ASSOCIATE:

Plasmid Purification Group

Incyte Pharmaceutical Inc. Palo Alto, CA

Performed various testing methods including cell cultured, cell isolation, and lyophilization.

Performed all tasks by using HPLC, high-tech incubator, centrifuge, balance, pH meter, and other related

instruments

SIGNIFICANT ACCOMPLISHMENT: Set up the system for the development to promote productivity

and reduce down time

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