Quality Control Manager
Resume:
Christina Nguyen
Home Phone: 626-***-**** Email: *****************@*****.*** 403 S. 8th
Street
Cell Phone: (626) Alhambra, CA
SUMMARY OF SKILLS
Eleven years of experience in the Method Development and Quality Control
fields in the areas of Research Associate, Technical Specialist and Data
Analyst Level II/Biochemist I. Ability to read and interpret technical
documents, such as production batch records, product specifications, and
procedural manuals. Dependable and committed to getting various tasks and
problems completed or resolved successfully. Excellent knowledge of Good
Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Lab
safety. Excellent written and verbal communication skills. Strong
organizational, analytical, and written skills. Capable of working
independently and efficiently with minimal supervision.
PROFESSIONAL EXPERIENCE
DIAGNOSTIC PRODUCTS CORPORATION/
SIEMANS HEALTHCARE DIAGNOTICS, LOS ANGELES Jun 2006 to
Present
Quality Control Data Analyst Level II/Biochemist I
. Adhere to scheduled due dates to ensure on-time release of specific
product(s) and carry out advanced planning of work assignments for
pending product releases based upon products due dates and components
availability.
. Generate work assignments for QC laboratory staff in accordance with
departmental procedures for in process, release and stability testing
of specific products.
. Interface with QC laboratory management to effectively schedule and
issue assignments.
. Interface with management to resolve issues related to product release
in order to ensure compliance to GMP/ISO regulations and to meet
Quality Control specification.
. Interface with personnel from various other departments of the company
in order to obtain necessary information.
. Review the Quality Control data for accuracy and completeness in order
to assure compliance with GMP, ISO 13485, Company standards and
procedures, and all other applicable regulatory.
. Perform various assays and trouble shooting when shortage of QC
laboratory staff.
. Review and make decisions based upon resulting data (release product
passing current specifications, initiate an investigation or issue
disposition for out-of-specification data).
. Responsible for effectively present summarized data packages to senior
level staff, typically in a one-on-one or small group situation, in an
organized and concise manner.
. Monitor product performance during in process, release and stability
testing.
. Write complex work assignments, change control, deviation, non-
conformance report and procedures.
. Train the weak members in QC laboratory and new comers in the group to
improve working laboratory knowledge, understanding of departmental
programs, and company policies.
. Promotion from Quality Control Technical Specialist to Quality Control
Data Analyst Level II in Jun 2006.
DIAGNOSTIC PRODUCTS CORPORATION, LOS ANGELES July
2004 to Jun 2006
Quality Control Technical Specialist
. Assisted senior level staff with the on-time release of quality
immunoassay products using established departmental procedures and
current specifications for specific.
. Generated work assignments for QC laboratory staff in accordance with
departmental procedures for in process, release and stability testing
of specific products.
. Reviewed the Quality Control data for accuracy and completeness in
order to assure compliance with GMP, ISO 13485, Company standards and
procedures, and all other applicable regulatory.
. Provided effective and efficient response to client inquiries and/or
complaints regarding the company products.
. Knowledge of products and product performance along with the ability
to run assay/instrumentation.
. Retained knowledge and became familiar with clinical applications of
products.
. Monitored product performance during in process, release and stability
testing.
. Wrote complex work assignments, change control, deviation, and non-
conformance report.
. Assisted Associate Director in training for new Quality Control
Manager on how to review the Quality Control data for accuracy and
completeness.
. Promotion from Method Development Research Associate to Quality
Control Technical Specialist on July 2004.
DIAGNOSTIC PRODUCTS CORPORATION, LOS ANGELES Jan
2002 to July 2004
Method Development Research Associate
. Performed research and development activities in cooperation with
other senior-level departmental staff and company management.
. Assisted the weak members and new comers in the group to improve
working laboratory knowledge, understanding of departmental programs,
and company policies.
. Performed stored curve, pre/post pack, CV, CPV (curve parameter
verifications) long and short runs, scaling, spiking and recovery,
method comparison in various ways, inter-assay, stability with vary
conditions and times.
. Performed troubleshooting kits, back-order kits and IMMULITE One,
1000, Turbo, 2000 and 2500 Instrument operation problems.
. Made buffers, Calibrators by weight and spiked to compare with
production method and expert on Coating Beads.
. Assisted Method Development department to control of community kits,
Calibrators, Controls and Coated Beads.
. Assisted the Lab Manager to keep track and ordered raw materials.
SAN GABRIEL VALLEY MEDICAL CENTER
1998 - 2002
Certified Nursing Assistant (C. N. A.)
. Took care of patients on the daily basic.
. Taught patients about safety while they were in the hospital or at
home.
. Assisted other staff when needed.
. Assisted supervisor to train new employees.
. Developed activities to entertain patients while they were in the
hospital.
. Operated Vital Signs, Scale, and Intra Vinous Pump machines.
COMPUTER EXPERIENCE
Strong Computer Skills in J.D Edward One World interface, Windows 2000
Professional, Windows 7, Microsoft Word, Excel, PowerPoint, Outlook,
Internet Explorer, Internet Utilities, Visual and Documentum.
EDUCATION
University of Southern California Los Angeles, California
1996-1999
Bachelor of Science in Nursing
CONTINUING EDUCATION & CERTIFICATIONS
. Age Appropriate Care Competency (one unit).
. Certified Nursing Assistant Annual Skills (eight units).
. Management Assault Behavior (four units).
. Swallowing Problems (one unit).
. Suicide Awareness (one unit).
. Basic Life Support Course (four units).
. Environmental Care (one unit).
. Employee of the Month Award in Method Development Department, December
2003
. Strong performance in the department Award October 2009.
. You answer Award March 2013.
REFERENCES
Available upon request
Contact this candidate