ABLA TOUNY

(***) ***- ****

909-***-**** **** Blue Fox Drive

acu4g2@r.postjobfree.com Ontario, CA 91761

VALIDATION/QUALITY ASSURANCE / RESEARCH / DEVELOPMENT SCIENTIST Staff Scientist with extensive expertise and a proven track record of success in leading development, performance verifi- cation and validation, quality assurance activities of complex clinical chemistry systems. Diverse experience as a Licensed Clinical Chemist, Clinical Toxicologist, Researcher and Sr. Technical Support Representative making a significant contri- bution in the development and testing of state of the art technologies, improving quality, reducing after sales cost and in- creasing customer satisfaction.

Key competencies includes:

PROFESSIONAL EXPERIENCE

Lab Support a division of on assignment, Nutraceutical Client Upland, CA 2015-2015 Consultant

• Carryout activities associated with the establishment of a Nutraceutical laboratory.

• Recommended laboratory layout and the required safety equipment.

• Reviewed the company products, identified assays, recommended the needed instruments and chemicals. BIO-RAD LABORATORIES, Diagnostic Group/Quality Control Program, Irvine, CA 2008 – 2015 Senior Technical Support Representative

• Carryout activities associated with performance verification/Instrument validation, identified enhancements and soft- ware anomalies of EQA database and software.

• Manage and test (EQA) External Quality Assurance programs databases.

• Perform in depth troubleshooting and data analysis for all EQA programs.

• Resolve and respond to customer complaints and inquires.

• Responsible for the classification and the construction of all EQA Programs Method Classification Guides, customer user documents and internal procedures.

• Write internal user requirements for the EQA databases for all programs; including new enhancements. BECKMAN COULTER, INC., Systems Validation/Quality Assurance, Brea, CA 1994 – 2008 Staff Development Scientist (2001-2008)

• Led and managed all systems validation line support, CAPA current businesses, obsolescence, customer complaints and after-sale cost reduction projects.

• Coordinated and prioritized multiple tasks and projects, maximized the utilization of available resources. Performance Verification and Validation/Experimental Design

Troubleshooting/Root Cause Analysis/Clinical

Toxicology/Clinical Chemistry/Technical Expertise

Test Plans/Testing Protocols/Presentations Supervision/Training/Technical Support Research/Development/Data Analysis Design Review/Risk Analysis/ FMEA Knowledge of pharmaceutical Autoclaving systems Strategic Planning/Systems QualityAssurance Knowledge of pharmaceutical CIP/SIP Systems Knowledge of Nutraceutical assays and processes

• Resolved performance, quality, obsolescence and stop ship issues.

• Reduced after-sales costs and increased customer satisfaction.

• Supported and participated in integration, verification and validation testing of the SYNCHRON LX20Pro/LXi725 and UniCel DxC600/800/600i Clinical Chemistry/Immunoassay Analyzers.

• Uncovered performance, quality, robustness and customer need issues early in the development process, leading to suc- cessful resolution prior to general release.

• Led performance verification and validation for a large chemistry menu expansion project, and identified onboard sta- bility, precision and recovery issues that were resolved prior to release.

• Led and managed performance verification and validation for several critical features including obstruction detection, closed container sampling capability, serum indices, photometer improvement and obsolescence projects. Successfully released cutting edge technology through good experimental design, data analysis and technical know-how.

• Strengths in root cause analysis, experimental design, writing protocols, test plans and reports.

• Attended and participated in Design Review and Risk Analysis meetings.

• Assisted and supported CAPA and customer complaint investigations and resolutions.

• Trained and guided junior staff.

Senior Scientist (1996-2001)

• Supported and participated in verification and validation testing of the SYNCHRON LX20/LX20 Pro Software upgrade projects.

• Identified several critical software issues that were corrected prior to release.

• Served as Systems Validation Lead and completed successfully and on time several Line Support and ASCOS (after- sales reduction) projects such as reagent pumps, vacuum pumps, level sense and smart module boards, sample and reagent probes and cuvette wipers.

• Orchestrated, designed and implemented “High Volume Study” to stress and evaluate the system performance in a high volume hospital environment, resulting in successfully uncovering several performance and robustness issues that were resolved prior to release.

Associate Scientist (1994-1996)

• Supported and participated in verification and validation testing of the SYNCHRON CX Systems Software projects and hardware upgrades.

• Operated and maintained instruments, performed data and root cause analysis where performance issues were identified, and recommended and implemented corrective actions.

• Supported and participated in the verification and validation testing of the CZE Systems Software projects and hard- ware upgrade.

PHYSICIANS CLINICAL LABORATORY, Toxicology Dept., Rancho Cucamonga, CA 1991 - 1994 Clinical Chemist Scientist

Performed all tests in the toxicology laboratory utilizing GC/MS, GC, TLC, RIA, HITACHI Auto Analyzer, TDX and ADX, Autoclaves.

• Contributed to enhancing company’s image and revenue through error reduction and timely response. EDUCATION/LICENSE

Bachelor of Science in Biology/Chemistry, The College of Staten Island, City University of New York, NY Clinical Chemist Scientist - State of California.

TECHNICAL:

GC/MS, GC, HPLC, Column Chromatography, TLC, Gamma Counters, Electrophoresis, Spectrophotometers,Flame Photometer, ACA, SYNCHRON CX3, SYNCHRON CX7, SYNCHRON LX20, SYNCHRON LXI 725,UniCel DxC, COBAS BIO, ADX, TDX, Hitachi Auto Analyzer, Paragon CZE, Auto- claves, Nutraceutical equipments, Excel, Word, SQL Plus, RS Client, and PowerPoint.

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