Efficient and results-driven Quality Management Systems professional seeking a position that will challenge my problem solving skills, and allow me to continue to develop my knowledge and potential in a renowned company. EXPERIENCE IN IMPLEMENTING QUALITY CONTROL SYSTEMS IN A MEDICAL DEVICE AND PHARMACEUTICAL MANUFACTURING ENVIRONMENT. ORGANIZED AND PROFICIENT IN MANAGING MULTIPLE TASKS SIMULTANEOUSLY AND COMPLETING THE TASKS ON TIME. Exceptional attention to detail, accurate, and reliable with uncompromising work ethic. Effective written/oral communication with strong customer service experience. Keen ability to problem solve, analyze nonconformities, and give recommendations according to quality requirements. Flexible to change and new challenges.
Summary of Skills
Data Analysis & Management Change Controls
Quality Metrics Lean 6 Sigma 2008
21 CFR Part 11 & 820
ICH, GMP, & GLP English, Vietnamese, & Hmong
Minitab, AutoCAD, & Master Control
Bachelor of Science:Biochemistry1 2010Drake University, Des Moines, IABiochemistry
SURMASIS PHARMACEUTICALDES MOINES, IAQUALITY SPECIALIST01/2013 to Current
Responsible for compliance of established standards of quality to cover the safety, design, production, and inspection of pharmaceutical transdermal products.
Proactively communicate with Engineering and Manufacturing to assure production goals are met and deviations are resolved in a timely manner to ensure product quality.
Supervise and train a team of two Quality Technicians.
Identify training needs and organize training interventions to meet quality standards.
Develop and evaluate standard operating procedures based on business process needs, gap analyses, and change controls.
Present quarterly reports to identify areas for improvement in the quality system.
Initiate, recommend, and monitor CAPA program to address deviations and out of specifications.
Maintain document control of compliance records such as receiving/inspection records, batch records, laboratory notebooks, and test reports.
Support on-site regulatory audits conducted by external providers as well as internal audits.
Support ANDA filing to FDA for pharmaceutical transdermal patches to meet regulatory requirements.
Involve in investigational & resolution process for both outgoing vendor complaints and incoming customer complaints.
Coordinate and monitor receiving, inspection, and testing of raw materials and finished products.
Manage and execute Validation and Verification of new test equipment & test methods.
Implement 5s program within quality test laboratories as well as relevant working areas.
KATECHO, INCDES MOINES, IATEST ENGINEER01/2010 to 01/2013
Managed, coordinated, and provided strategic planning of activities for development of new or improved concepts and applications for medical devices for testing and engineering R&D programs.
Supervised a team of four R&D Test Lab Technicians.
Authored test methods, analyzed test results, and prepared reports to communicate outcomes of new and existing product.
Held weekly presentations to board of directors and CEO on new product testing and opportunities for improvement on existing products.
Assisted in 510k submissions to FDA for various medical device products.
Planned and managed testing product performance, quality, and stability studies to establish product shelf-life.
Implemented automated testing of medical electrodes and eliminated redundancies in test procedures ensuring testing reliability and productivity.
Enforced quality check points throughout work processes to identify and eliminate the source of errors increasing testing accuracy.
Responsible for Qualification and Validation of new test methods and equipment.
DES MOINES UNIVERSITYDES MOINES, IAMICROBIOLOGY/IMMUNOLOGY LAB ASSISTANT01/2009 to 01/2010
Prepared microorganism cultures and reagents for use within laboratory.
Performed various experimental techniques including: PCR, DNA Purification & Extraction, Gel Electrophoresis, Molecular Cloning, and Spectrophotometry.
Conducted presentations including a formal paper on "The Presence of Integrons in Salmonella Chromosome" at Drake Conference on Undergraduate Research in the Sciences.
Significantly contributed to the research of molecular characterization of antimicrobial resistance genes in Salmonella from humans and animals.
ERESEARCH TECHNOLOGY, INCPHILADELPHIA, PASENIOR CARDIAC SAFETY SPECIALIST01/2007 to 01/2008
Collaborated with Project Management and Quality teams to ensure accurate study protocol setup.
Evaluated data collection plans and initiation packets for protocol specific client assignments.
Supervised a team of eleven Cardiac Safety Specialists.
Promoted to Senior Cardiac Safety Specialist as a result of consistent high performance and key relationship building.
Improved the accuracy and productivity of the Quality Assurance Program, department competency testing, and metric collection testing programs.
ERESEARCH TECHNOLOGY, INCPHILADELPHIA, PACARDIAC SAFETY SPECIALIST01/2004 to 01/2005
Collaborated with Quality teams to ensure accurate measurement of electrocardiograms for various studies.
Maintained a low 3% error metric and advanced the production and quality of work of Cardiac Safety Specialists.
21 CFR Part 11, AutoCAD, business process, client, data collection, Data Analysis & Management, English, filing, GLP, GMP, ISO 9000, notebooks, materials, Microsoft Office, Minitab, PCR, presentations, processes, Project Management, Quality, Quality Assurance, receiving, relationship building, Research, Safety, Sigma, strategic planning, test equipment, Validation, Vietnamese