Biological Sciences Professional, with multi-facetted experience in working in Forensic Analyst, seeking to utilize Investigative, Staff Training and Customer Support capabilities in a challenging assignment

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 9001:2008 / ISO 13485:2003

Korean Language Proficiency

  Over twelve years of professional career background in medical device manufacturing sector as well as multiple laboratory and microbiology-related assignments; proven success in performing crucial research activities as well as performing outstanding team development

  Continually utilize excellence in personnel direction and oversight to drive organizational effectiveness; adapt quickly to difficult situations and employ outstanding strengths in conceptualizing solutions to complex situations while employing practical strategies

  Skilled in assuring comprehensive monitoring of complaints including reporting to relevant entities within optimal timeframe; assume responsibilities for reviewing, approving and closing exceptionally-complex products and reportable complaints

  Provide subject matter expertise in directing investigations performed by multiple subordinate Analysts; major contributor to development and implementation of new complaint submission process that increased interaction/communication

  Author reports and provide input regarding reportability and compliance with foreign and domestic regulations covering medical device complaints; exceptional skills in analyzing and documenting complaint trending

Advanced Sterilization Products (Johnson & Johnson), Irvine, CA 2010 - Present

Senior Customer Quality Specialist (2012-Present)

         Effectively employ subject matter expertise to monitor international complaint reporting; consistently assure complaint reporting managed in timely manner, with responsibilities for reviewing/approving/closing complex products and reportable complaints.

         Steer training of ten onsite junior analysts/15 offshore analysts in proper methods for complaint analysis/investigation/resolution; during a single year successfully resolved 24K international complaints.

         Major contributor to design/implementation of complaint submission process designed to increase interaction/communication levels; also streamlined RMA process to reduce cycle time from two-month average to one day, resulting in negation of compliance issues/problems.

         Author/file MDRs, provide input on MDR guidelines for reportability and ensure compliance with foreign/domestic regulations regarding medical device complaint managing; analyze complaint trending, respond to monthly audit results and participate in weekly Adverse Event meetings covering handling of reportable events/situations and methodologies for retrieving important, time-sensitive information.

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Product Complaint Specialist (2010-2012)

         Diligently analyzed/resolved approximately 5,000 complaints regarding capital equipment/consumables; successfully met tight turnaround timeframes for delivering MDR/MDV reportable files.

         Skillfully employed multiple statistical process controls to identify complaint trending, assess low-/high-risk complaints and review complaint investigations; performed comprehensive management of complaint records, follow-up with customers and field service individuals and verified product returns.

Dr. Stephen Prepas, MD., Newport Beach, CA 2009 2010

Optician

         Expertly supported Physician as well as customers with a wide array of professional services in this high-volume optical practice; fitted patients with contact lenses and eyeglasses and resolved any issues/problems.

         Also provided administrative assistance in various office-related duties including ordering products and performing inventory control, various receptionist functions and interfacing with vendors/sales representatives for purchasing needed items such as frames.

NAMSA, Irvine, CA 2009

Microbiology Sterility Technologist II

         Adroitly performed array of sterility testing and Quality Control processes on bacterial spores/media; directed environmental monitoring and cleaned/disinfected cleanroom Class 10,000 and Class 100,000.

KIK Custom Products/Lab Support, Hacienda Heights, CA 2008 2009

Quality Assurance Microbiologist

         Conducted multiple QA tests of finished products/raw materials based on customer inquiries/complaints; monitored environment regarding microbial air, surfaces/particulate air, water quality, sterility levels and growth promotion; also prepared various media and maintained stock cultures.

Advanced Sterilization Products (Johnson & Johnson), Irvine, CA 2007 2008

Senior Quality Technician (Microbiology)

         In this initial Contractor assignment for company, performed multiple QA tests on raw materials/finished products in response to complaints involving 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; also led team of four Technicians and performed design validation testing on capital equipment systems.

Center for Molecular and Mitochondrial Medicine and Genetics (MAMMAG), Irvine, CA 2003 2007

Laboratory Assistant

         Successfully performed multiple duties including autoclaving, filling laboratory orders, stocking gel, PCR and gel electrophoresis.

University of California-Irvine, Irvine, CA, Bachelor of Science, Biological Science, 2007

Dean s Honor List Member, 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