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Christine
Wu
Christine Wu
Sr. Customer Quality Specialist
Advanced Sterilization Products
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19394 Highridge way
Trabuco Canyon
CA
92679
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7143226220
N/A
Devices, Pharmaceuticals, Biologics, Biotechnology
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Christine (Rina) Wu
19394 Highridge Way, Trabuco Canyon, CA 92679 ● (714)322-6220 ● rinayi@gmail.com

OBJECTIVE

Seeking to expand my knowledge and experience in the medical device industry in a position where my results-driven work ethic, attention to detail, solid collaboration skills, and strong analytical capacity is required.

EXPERIENCE

Advanced Sterilization Products, a Johnson & Johnson company Irvine, CA
Senior Customer Quality Specialist April 2012– Present
• Trained and coordinated 10 on-site junior analysts to analyze, investigate, and resolve complaints resulting in the resolution of 24,000 international complaints within one year
• Reviewed, approved and closed high visibility product and reportable complaints. Ensured quality issues were investigated, resolved and closed in an effective and timely manner.
• Developed and deployed new complaint submission process to enhance collaboration between WW affiliates resulting in improved relations and communication
• Trained and led an offshore team of 15 analysts by managing their complaints entry workflow
• Responsible for monitoring worldwide complaints reporting for the company and driving complaints reporting timeliness
• Streamlined Return Materials Authorization process that resulted in the cycle time reduction from an average of 2 months to 1 day to avoid compliance issues.
• Supported the backroom operations of a key FDA audit

Advanced Sterilization Products, a Johnson & Johnson company Irvine, CA
Product Complaint Specialist I May 2010 – April 2012
• Analyzed, investigated, and resolved approximately 5,000 capital equipment and consumable complaints meeting aggressive deadlines including MDR/MDV reportable files
• Trended complaints using statistical process controls
• Reviewed low and high risk complaints and assesses complaint investigations assignments
• Managed complete complaints records compliance through follow-up with customer and field service staff and verification of product return

Dr. Stephen Prepas, M.D. Newport Beach, CA
Optician August 2009-May 2010
• Maintained a high-level of customer satisfaction performing receptionist and optician duties in a busy work environment, in addition with handling customer complaints with their orders and service
• Oversaw ordering, stocking, maintaining relations with sales representatives for frames
• Fitted patients with glasses and contacts

NAMSA Irvine, CA
Microbiology Sterility Technologist II January 2009 – August 2009
• Performed sterility testing and quality control procedures on bacterial spores and media
• Conducted Environmental Monitoring including cleaning and disinfecting cleanroom Class 10,000 and
Class 100,000

KIK Custom Products /LabSupport Hacienda Heights, CA
Quality Assurance Microbiologist September 2008 – January 2009

• Performed Quality Assurance testing of finished products and raw materials for customers and customer complaints
• Performed Environmental Monitoring (microbial air, surfaces, and particulate air), water testing, sterility
check, growth promotion, media preparation, and stock culture maintenance

Advanced Sterilization Products, a Johnson & Johnson company/Kelly Services Irvine, CA
Sr. Quality Technician (Microbiology) September 2007 – September 2008
• Performed Quality Assurance testing of finished products, raw materials, and complaints of biological indicators.
o H2O2 biological indicator resistance testing on finished products.
o Titers, Plate count, Isolation, preparation for microbial identification
• Performed biological indicator testing for complaints investigations.
• Supervised daily activities of a team of 4 technicians
• Executed design validation testing on the capital equipment systems

EDUCATION
University of California, Irvine Irvine, CA
Bachelor of Science, Biological Sciences September 2007
Honors: Dean’s Honor List Winter ’06, Spring ‘06
Sports: Women’s Crew 2006


SUMMARY OF SKILLS



• Familiar with Internal Auditing
• cGMP documentation
• Aseptic Lab Techniques
• ISO 9001:2008, ISO 13485:2003

• Computer Programs: Siebel Complaints Handling System, Service Alliance field service management platform, Microsoft Office
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