arleen figueroa
validation manager
About
Experience at the Pharmaceutical Industry at bulk (solid dosage) manufacturing, packaging, validation area and Medical Device industry. Fully bilingual, team work oriented with excellent interpersonal skills, willingness to learn and adopt concepts and technologies, committed and focused on results.
puerto rico
puerto rico
industrial automation
gmp, validation, capa, pharmaceutical industry, fda, quality assurance, quality system, manufacturing, change control, v&v, medical devices, continuous improvement, minitab, 21 cfr part 11, cleaning validation, computer system validation, engineering, root cause analysis, sop, six sigma, trackwise, lean manufacturing, iso, sap, packaging, technology transfer, quality auditing, quality control, cross functional team leadership, process engineering, product development, fda gmp, gxp, pharmaceutics, quality management, fmea, equipment qualification, process simulation, design of experiments, calibration, biopharmaceuticals, regulatory requirements, lims, standard operating procedure
Experience
packaging technical service specialist
mentor technical group corporation
* Day to day tasks for the Packaging Technical Service for Bottles and Blister Process. * Generation and routing for Quality Assurance documents such as CAPA and QAR’s, Notice of Observations. * Develop investigations and product complaint responses within expected time and necessary technical information. * Generation, review and approval of Qualification / Validation documentation for packaging process or equipments.
validation specialist
mentor technical group corporation
validation manager
ultimate solutions corp.
* Planning and monitoring projects. * Monitoring overall progress and use of resources, initiating corrective action where necessary. * Plan and manage deployment of physical and financial resources to meet project milestones. * Develop project schedule, quotes, financial management. * Direct, manage and motivate resources. * Develop and execute equipment and serialization qualification / validation protocols.
packaging engineer
bristol-myers squibb
* Responsible for providing technical support for packaging lines including investigation (QE) and correction (CAPA) of process related problems and deviations from standards. * Provide support for packaging related APQR’s. * Designs and executes process and component qualifications and validations. Review and approve product bill of specifications. Complete change controls and corresponding documents and reports for packaging equipment and processes. * Review component issues or defects with supplier and Global Packaging Technology (GPT) group in order to prevent downtime and achieve line efficiency. * Serves as technical expert for assigned projects, such as product launches, equipment, product and packaging process qualification. * Serves as technical expert for assigned products and/or packaging lines during inspections.
engineering specialist
medtronic
* Generate equipment/process validations and all supporting documentation related to the new product transfer according to plant guidelines and project timelines. * Developed and generated process deviations investigations and operation procedures (SPOD’s) documentation. * Analyze data with Medstat for Excel and/or MiniTab in order to obtain statistical output to attain the operational control limits.
Education
notre dame high school
universidad del turabo
mechanical engineering
Served as Mentor (tutorial) for algebra and pre-calculus classes. * Secretary of ASME college chapter. * Founder and former president of Tau Alpha Omega Honor Society (in order to become Tau Beta Pi college chapter). * Participated as an intern student at NASA John F. Kennedy Space Center. * Collaborated in a team effort a proposal for a design of an electrical back-up generation system for production Building B at Pfizer Caguas site, PR. * Received the 2003 Distinguished Senior Student Faculty Award for the Mechanical Engineering Department. Activities and Societies: ASME, SHEP, TAU ALPHA OMEGA
arleen figueroa's Contact Information
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