Senior QA/Test Engineer with full system development lifecycle experience, including designing, developing, and implementing test plans, test cases, and test processes. Offer significant achievements driving cost savings, process efficiency, and fault-free audits. Skilled in Agile methodologies with strong leadership and strategic thinking skills. Proven ability to identify business needs and develop valuable solutions to improve accuracy and process efficiency. A strong team player with excellent communication and interpersonal skills.
Education and Training
Master of Science : Pharmaceutical Systems Management, 2013NEW JERSEY INSTITUTE OF TECHNOLOGY － Newark, New JerseyPharmaceutical Systems Management
Bachelor of Science : Biology, 2008RUTGERS UNIVERSITY & NEW JERSEY INSTITUTE OF TECHNOLOGY － Newark, New JerseyBiology
Test and Evaluation (T&E)
Writing use cases
Expert in data analysis
Team Foundation Server
Microsoft Test Manager
Analytical problem solving
Sr. Software QA Engineer May 2014 to CurrentSIEMENS HEALTHCARE DIAGNOSTICS － TARRYTOWN, NEW YORK
Responsible for Software and System Verification and Validation activities intended for next generation Immunoassay Chemistry In Vitro Diagnostics Analyzer.
Designed, developed and implemented effective tests protocols to verify that the system complied with requirements.
Used Orthogonal Arrays Test Strategy to lead testing in the pursuit of high quality test designs.
Performed continues integration testing across multiple platforms, resulting in fast defect discovery.
Testing the application structures and functionality's for grey box and black box testing.
Drove test execution within fast-paced, agile development environment.
Developed, maintained and approved quality related processes to continually improve performance.
Managed and drive test schedule and related activities.
Demonstrated debugging skills in a complex automated instrumentation environment, including hardware, software, and mechanical components.
Collaborated with software and hardware development team for verification and validation activities.
Evaluated and analyzed qualification data collected during projects, while verifying acceptability of the data and compliance with the approved protocols.
Used monitoring tools such as Dev Track ,Team Foundation Server, MTM and RdExpert.
Product Quality Engineer April 2013 to April 2014SIEMENS HEALTHCARE DIAGNOSTICS － TARRYTOWN, NEW YORK
Responsible for leading Methods Integrations V &V test activities in bridging the functions and validating of instrument system development and assay development for ADVIA Centaur XP/XPR Immunoassay in vitro diagnostic (IVD) instruments and accompanying laboratory automation.
Supervised, assigned tasks and provided technical guidance to the V&V team during the test protocol development and test execution phases.
Monitored testing progress, tracked and reported quality goals for the project.
Design experiments and provide rapid and accurate diagnostic testing for clinical laboratories working with infectious diseases, oncology, cardiac markers, fertility testing, thyroid function, and other clinical applications.
Created systems validation plans that outlined the systems validation approach.
Selected the proper testing techniques and methodologies to use in the design studies development.
Developed business-focused regression test scenarios and test scripts for existing systems to ensure that previous errors are fixed, no new errors are introduced and the system functions as intended.
Developed design studies based on the software, system, system user interface, system use cases and hardware requirements.
Implemented design changes by creating, executing, analyzing and reporting on verification and validation activities for immunoassay systems.
Researched field complaints and performed root cause investigations to identify solutions.
Assessed field safety issues by performing cross-functional risk assessments and generating product safety reports detailing safety risks, severities, probabilities, and mitigations.
Investigated and resolved Corrective and Preventive Action Plans (CAPAs).
Reviewed and analyzed test results and documented deviation found using Defect Tracking Systems and Application Lifecycle Management tools.
Generated validation summary reports that concluded the test results and the overall quality level for the project.
Participated in formal systems design reviews, requirements analysis and change control board meetings.
Medical Technologist April 2009 to April 2013BIO-REFERENCE LABORATORIES － ELMWOOD PARK, NEW JERSEY
Concurrent with graduate education in Pharmaceutical System Management, prepare specimens and conduct laboratory assays in Special Coagulation in support of disease diagnosis, treatment, and prevention.
Develop novel test methods, protocols, and reference ranges for in-house Special Coagulation tests, perform validation and statistical analysis of performance of all reagents and instrumentation, and prepare, edit, and cross-check reports of lab results.
Employ standard laboratory test and measurement controls to regularly assess quality control levels in compliance with CAP, safety, and risk-management guidelines and all other governing regulations and protocols; maintain cleanliness of lab equipment, instruments, and work area.
Provide technical supervision and mentoring to new associates in laboratory processes and procedures.
Conducted well-received research study, "Can ETP Be Used as a Clinical Assay in a Clinical Laboratory Setting?" for 2011 annual meeting of The American Society of Hematology (ASH).
Commended by supervisors for timeliness and precision in completing routine and special laboratory assays of patient blood and plasma specimens.
Performed Special Coagulation assays to include bleeding and clotting time, lupus inhibitor, mixing studies, general thrombophilia, and pregnancy tests.
Conducted ELISA assays including Protein Z, FX Antigen, Free Protein S Antigen, Protein C, Protein S, Immunoglobin G & M, and Collagen Binding assays.
Facilitated Special Coagulation Molecular Biology assays such as FV Leiden, Prothrombin, MTHFR C677, and MTHFR 1298 gene mutation tests.
Successfully collaborated with cross-functional team to clearly communicate test results to physicians, pathologists, and lab supervisor in support of provision of exemplary patient care.
Substantially increased departmental productivity and reduced turnaround by always completing and reporting patient test results within established timeframes.
Designed and formatted technical specification documentation, including architecture diagrams and process flows, to describe necessary system changes during test development and QA phases.
Scientist I July 2008 to April 2009EMCURE PHARMACEUTICALS － EAST BRUNSWICK, NEW JERSEY
Structured and conducted analytical and physical tests on raw materials, diligently following United States Pharmacopeia (USP) Monograph and Food and Drug Administration (FDA) guidelines for active and inactive drug substances to optimize pharmaceutical quality control / management operations.
Performed physical tests to include particle size analysis, bulk density, tap density, sieve analysis, loss on drying, heavy metals, residue on ignition, assay by titration, pH, identification tests on infrared (IR), ultra violet (UV) testing, thin layer chromatography, microscope testing, and diverse identifications tests; calibrated and utilized balances, Karl Fischer titrator, ATM sonic sifter, bulk tap density tester, gauge meter, Fourier transform infrared spectroscopy (FT-IR), UV-vis spectrophotometer, atomic absorption spectrometer, and Accumet pH meter.
Provided comprehensive project support to High Pressure Liquid Chromatography (HPLC) Lab and Analytical and Formulation Research and Development (R&D) Department.
Performed IR and UV tests on raw materials of R&D samples, stability samples, finished products, and in-process samples.
Ensured seamless compliance with corporate standard operating procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) through exact generation of logbooks, data printouts, databases, and notebooks outlining daily assay, process validation, and cleaning validation activities.
Provided on-going environmental monitoring of hazardous liquid chemical environment, immediately reporting incidents to supervisor in support of OOS and OOT deviation reporting.
Honed solid command of USP pharmacopoeia, ICH guidelines, and FDA rules and regulations.
Knowledge of quality regulations and standards.
Special Coagulation Department
Protein Z, FX Antigen, Free Protein S Antigen, Protein C, Protein S, Immunoglobin G & M, and Collagen Binding Molecular Biology assays: FV Leiden, Prothrombin, MTHFR C677, and MTHFR 1298 gene mutation tests Immunoassays: Allergy, Anemia, Bone, Cardiovascular, Diabetic, Hepatitis and HIV, Immunosuppressant, Liver Fibrosis, Metabolic, Reproductive Endocrinology, Sepsis, TDM, Thyroid Function, ToRCH and Special ID, Tumor Markers/ Oncology Physical tests: Particle size analysis, bulk density, tap density, sieve analysis, loss on drying, heavy metals, residue on ignition, assay by titration, pH, identification tests on infrared (IR), ultra violet (UV) testing, thin layer chromatography Equipment: Siemens ADVIA Centaur XP/XPR Immunoassay (IVD) instruments, Siemens BCSXP for special coagulation assays, Stago CAT, Stago STAR evolution XPS for clotting assays, Invader GenMark eSensor for molecular assays, Chronolog Aggregometer, Hologic TECAN, balances, Karl Fischer titrator, ATM sonic sifter, bulk tap density tester, gauge meter, Fourier transform infrared spectroscopy (FT-IR), UV-vis spectrophotometer, atomic absorption spectrometer, Accumet pH meter, medical devices Software: Dev Track ,Team Foundation Server, MTM, RdExpert, Lotus Notes, Microsoft Office Suite, Visio, MS Project Continued... Continued... Continued...