Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000

xxx-xxx-xxxx

abc@xyz.com

Country of Citizenship: United States

SSN: xxx-xx-xxxx

____________________________________________________________________________

Job Title:

Department:

Agency:

Core Competencies

Complaint Management/Resolution, Cross-Functional Team Involvement, Subordinate Personnel Training, Complaint Investigation Oversight, Process Development/Improvement, Medical Device Report (MDR) Filing, Complaint Trend Analysis, Internal Audit Involvement, Customer Interaction, Subject Matter Expert, Sterility Testing, Environmental Monitoring, Cleanroom Class 10,000, Cleanroom Class 100,000, Product Quality Assurance Testing, Inventory Control, Vendor Interface

Siebel Complaints Handling System, Service Alliance Field Service Management Platform, Microsoft Office Suite, Quality System Requirements, cGMP Documentation, Aseptic Lab Techniques, ISO 9001:0000 xxxxxx xxxx , xxxx , xxxxx 00000:2003

Korean Language Proficiency

Professional Experience

April 2012 - Present

Advanced Sterilization Products (Johnson & Johnson)

Irvine, CA

Hours per Week: N/A

Salary: $87,500 Annually

Supervisor: Denette Neris Phonexxx-xxx-xxxx May Not Contact

Senior Customer Quality Specialist

Effectively utilize strong skills and experience in monitoring reporting of complaints to include comprehensive worldwide involvement; diligently assure that complaint reporting is managed in timely manner and hold responsibilities for reviewing, approving and closing highly complex products and reportable complaints.

Employed subject matter expertise while conducting training and approving of completed investigations of ten onsite junior analysts and 15 offshore analysts on complaint analysis, investigation and resolution methodologies; successfully resolved 24,000 international complaints in one year. Major contributor to development/implementation of new complaint

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submission process that increases interaction and communications among participants; also streamlined RMA process to reduce cycle time from two-month average to one day, resulting in negation of any compliance issues.

Author/file MDRs, provide input on MDR guidelines regarding reportability and assure all needed compliance with foreign/domestic regulations concerning managing of medical device complaints. As Subject Matter Expert, diligently analyze and document complaint trending and respond to results of monthly internal audit findings; regularly participate in weekly Adverse Event meetings that focus on potential reportable situations/events and methodologies to use for retrieving needed, time-sensitive information.

May 2010 April 2012

Advanced Sterilization Products (Johnson & Johnson)

Irvine, CA

Hours per Week: N/A

Salary: $73,000 Annually

Supervisor: Carol Stoneman Phone: 949.789.8681 May Contact

Product Complaint Specialist

Successfully analyzed and resolved approximately 5,000 complaints involving capital equipment and consumables and met tight deadlines in delivering MDR/MDV reportable files. Expertly utilized array of statistical process controls to identify complaint trends, assessed low-/high-risk complaints and reviewed complaint investigations. Assured comprehensive management of complaint records, conducted follow-up with customers/field service personnel and verified product return.

August 2009 May 2010

Dr. Stephen Prepas, M.D.

Newport Beach, CA

Hours per Week: N/A

Salary: $24,000 Annually

Supervisor: San Kong Phone: 949.664.7926 May Contact: N/A

Optician

Provided outstanding expertise and customer support; performed wide array of duties in this high-volume practice including fitting patients with glasses and contact lenses as well as remediating any customer problems/issues. Additionally, performed administrative functions including receptionist support, product ordering, inventory control and working closely with vendors/sales representatives for frame products.

January 2009 August 2009

NAMSA

Irvine, CA

Hours per Week: N/A

Salary: $40,000 Annually

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Supervisor: Gowri Arumuli (no longer with company) Phone: N/A May Contact: N/A

Microbiology Sterility Technologist II

Tasked with conducting multiple sterility testing and Quality Control processes on bacterial spores/media; also directed environmental monitoring as well as cleaning/disinfecting cleanroom Class 10,000 and Class 100,000.

September 2008 January 2009

KIK Custom Products/Lab Support

Hacienda Heights, CA

Hours per Week: N/A

Salary: $14/Hour

Supervisor: Cecilia Garcia Phone: 626.333.3007 May Contact: N/A

Quality Assurance Microbiologist

Conscientiously performed array of QA tests of finished products as well as raw materials in response to customer inquiries/complaints; also monitored environment, i.e. microbial air, surfaces and particulate air, tested water, checked sterility levels and growth promotion, prepared various media and maintained stock cultures.

September 2007 September 2008

Advanced Sterilization Products (Johnson & Johnson)

Irvine, CA

Hours per Week: N/A

Salary: $14/Hour

Supervisor: Lindy Sum Phone: 949.789.8529 May Contact

Senior Quality Technician (Microbiology)

In this Contract assignment through Kelly Services, adroitly conducted multiple Quality Assurance tests on raw materials as well as finished products, with a focus on addressing complaints concerning various biological indicators. Performed H₂0₂ biological indicator resistance testing on finished products, titer testing, plate count, isolation and preparation for microbial identification, and biological indicator testing for complaint investigations. Directed work performance of team of four Technicians and performed design validation testing on capital equipment systems.

October 2003 April 2007

Center for Molecular and Mitochondrial Medicine and Genetics (MAMMAG)

Irvine, CA

Hours per Week: N/A

Salary: N/A

Supervisor: N/A Phone: N/A May Contact: N/A

Laboratory Assistant

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Skillfully supported organization by efficiently performing broad-based duties that included autoclaving, fulfilling various laboratory orders, stocking gel, PCR and gel electrophoresis.

Education

University of California-Irvine, Irvine, CA

Bachelor of Science, Biological Science, 2007

GPA: N/A

Semester/Credit Hours: N/A

Dean s Honor List Member, Winter/Spring 2006

Santa Ana College, Santa Ana, CA

Physiology Studies, Summer 2010

Orange Coast College, Costa Mesa, CA

Anatomy Studies, Fall 2009

Irvine Valley College, Irvine, CA

Communications Studies

Internship

Tufts University, Boston, MA

Kumamoto Laboratory, Sackler School of Biomedical Sciences

Assignment: Mapped mechanism of Candida Albicans resistance to the drug Fluconazole Summer 2005

Certification

Pathwise Technical Writing

Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000

xxx-xxx-xxxx

abc@xyz.com

Country of Citizenship: United States

SSN: xxx-xx-xxxx

____________________________________________________________________________

Job Title:

Department:

Agency:

I am extremely interested in being considered for the (vacancy/position/announcement) position available with your organization and am submitting my resume for review; I believe you will find my background strongly matches the requirements of this position. In particular, with a B.S. in Biological Science and experience gained during nearly 13 years of successful involvement in biological science and product research and analysis, I am well-versed in managing operations, meeting standards and guidelines, and achieving objectives.

In my current position as a Senior Customer Quality Specialist for Advanced Sterilization Products, which is part of Johnson & Johnson, I am tasked with utilizing my in-depth subject matter expertise to oversee the addressing and remediation of customer problems/issues on a worldwide basis. In this endeavor I continually work closely with cross-functional teams in driving toward issue resolution and achieving customer satisfaction in a highly regulated environment.

Additionally, I am tasked with providing leadership, training and direction for onsite as well as offshore junior analysts regarding complaint analysis, investigation and resolution. Under my direction, our team successfully resolved over 24,000 international complaints within a single year. I have been a major contributor to the development and implementation of a new complaint submission process that increased interaction and communication levels among participants and I have led efforts to streamline the RMA process that reduced cycle time from an average duration of two months to one day. As Subject Matter Expert, I provide input on MDR guidelines concerning reportability and assure compliance with foreign and domestic regulations concerning the managing of medical device complaints.

Earlier assignments have included Product Complaint Specialist, Microbiology Sterility Technologist II, Quality Assurance Microbiologist, Senior Quality Technician (Microbiology) and Laboratory Assistant as well as an Internship at Tufts University s Kumamoto Laboratory, Sackler School of Biomedical Sciences, in Boston, MA.

Throughout my career I have exhibited a commitment to quality and consistent compliance with critical governing directives, standards, policies and procedures. I am confident in my ability to deliver immediate and long-term results and you will find me to be a performance-driven leader and collaborative team player focused on achieving and surpassing goals. I am eager to discuss how my qualifications match your needs, and look forward to interviewing with you at your earliest convenience. In advance, thank you for your time and consideration.

Professionally,

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