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Click here or scroll down to respond to this candidateCandidate's Name
Street Address E. Sahuaro Dr.Scottsdale, Arizona. Street Address
E-mail: EMAIL AVAILABLECellular Phone: PHONE NUMBER AVAILABLEEDUCATIONMaster of Education Years attended: 2008-2012NORTHERN ARIZONA UNIVERSITYBaccalaureate of Science in Chemistry Years attended: 1991-1996UNIVERSITY OF ARIZONA TUCSON, ARIZONARELATED COURSE WORKCalculus, Vector Calculus, Physics, Biology, Microbiology, Geology, Astronomy, Spanish, Business Management, Human Resources, Marketing, and Statistics.EMPLOYMENTQualityWEST Pharmaceuticals Years Employed: 2019-PresentAs a Quality Engineer, I am task to handle projects and initiatives, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements.Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards. Support technical and design review activities as a Quality Engineer SME Review and approval of qualification documentation and reports. Process, assist and provide guidance on any nonconformance that may occur and work cross-functionally with individuals, projects or extended teams to ensure success of projects.Facilitate and attend program meetings as required as part of extended program teams Liaison with company and customers on Quality matters. Provide Quality oversight of qualification/validation/design controls activities and provides quality oversight to the Research & Development (R&D) organization while working within a multi-functional team environment for medical devices. Process and execute transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including site audit support.Fluent in MasterControl, SAP, Share Point and experience with Project Management, and Quality Risk Management. Familiar with regulatory guidance such as ISO 13485, 21 CFR 820.30 and supporting incoming inspection and reporting and working with suppliers on CAPAs. Experience with drug handling and medical device regulations (21 CFR 210, 211, and 820).Quality Compliance SpecialistArizona Nutritional Supplements Years Employed: 2013-2019Follow and ensure compliance to quality system and cGMP programs; Review batch records for completeness and accuracy and ensure that Current Good Manufacturing Practices/Good Procurement Practices were followed, consulting with supervisor if needed; Release or reject product based on testing results against specifications and completeness of batch record documentation; Coordinate the release and approval of all Supplement Fact Panel/Nutritional Fact Panel (SFP/NFP) components, while ensuring that Standard Operating Procedures (SOPs) were followed, from receiving to release, and all company needs are satisfied; Generate Certificates of Analysis for finished goods and send to appropriate salesperson, Customer Service Representative, and/or customer; Catalog, box up and store sample retentions. If needed, pull retention from storage and ensure completeness of necessary documentation; Quarantine and destroy obsolete packaging components that bear SFP/NFP; Maintain detailed log, and keep complete and accurate records such as emails, label release sheets, and scrap notices.Center Quality Manager Years Employed: 2009-2013IBR/Talecris Plasma ResourceEnsures center compliance with quality standards and regulations. Hosts audits with assistance. Directly reports to the Lead Quality Supervisor with a dotted line to the Director of Field Quality, but works under the indirect supervision of a Center Manager. Collaborates with Center Managers to ensure product quality.Observes processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Ensures that Standard Operating Procedures (SOPs) are updated and validated and that staff performs according to all SOPs. Oversees shipments: ensures shipments meet specifications and requirements; ensures accurate labeling and documentation; and, authorizes final shipments. Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports all incidents to Center Manager. Reports compliance status to necessary parties. Ensures accuracy of donor files. Ensures that all supplies and materials ordered meet quality regulations. Directs the maintenance and calibration of equipment and documentation of procedures. Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented. Monitors training documents to ensure compliance with all applicable policies and procedures. Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file. Oversees execution, documentation, and review of internal and external audits. Tracks and follows-up on corrective actions and preventative measures. Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents. Updates the Center Procedure Manual with the most recent approved procedures and forms. Implements continuous quality improvement. Prepares quality analysis reports to track issues and set goals. Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation.Quality Manager Years Employed: 2006-2009Tri-State Hospital Supply CompanyResponsible for managing analytical testing and inspection of medical products at Yuma, AZ facility in conformance with FDA Quality System Requirements, ISO 13485, CE Medical Device Directive, and other regulatory requirements. Position reports to the Director of Quality Assurance & Regulatory Affairs located at the corporate headquarters. Responsibilities include: Manages day-to-day activities and staff within the laboratory. Oversees incoming, in-process, and final inspection activities and staff. Assesses needs and makes recommendations for ensuring adequacy of resources. Acts as liaison between local quality/lab groups and corporate QA/RA office, and ensures regulatory compliance for the facility. Develops and oversees validations, quality documentation, and interaction with customers and outside laboratories. Handles regulatory inspections and ISO and customer audits of the quality system. Assists in developing laboratory guidelines, maintaining procedures manuals and ensuring adherence to Good Laboratory Practices (GLP). Trains personnel in proper lab and quality control methods.Q.A. Chemist/Scientist Years Employed: 2004-2006Medi-Flex, Inc.Responsible for overall Regulatory Compliance both GLP/GMP, as well as, ISO 9000-2002 in the areas of Chemistry, Microbiology, and Formulation; Responsible for temperature monitoring, and environment monitoring utilizing the MET One Particle Counter, the Retro Centrifugal Systems (RCS), Multi-point Temperature recording devices, and RODAC plates; Familiar with basic principles of microbiology including preparing medias and identification of bacteria; Responsible for the Sterility release of product using biological indicators; Familiar with autoclave functions and procedures; Responsible for the microbiological testing of USP grade de-ionized water and all formulations; Responsible for sampling and testing of raw materials both the identification and release of incoming materials, as well, as annual verification of vendors; Responsible for formulated product testing and standardization and maintaining of test solutions; Develop, implement and maintain procedures for laboratory function; Perform Production Review Investigations relative to formulation non-conformances; Perform Internal Audits; Maintenance of department budgets; perform and evaluate Validations; Perform Engineering tests and hypothesis testing and statistical evaluations; Perform stability studies; Assist in troubleshooting efforts; Responsible for the implementation and maintenance of quality systems relative to formulation, water system utilizing the Anatell 643 TOC Analyzer and chemical analysis utilizing High Performance Liquid Chromatography (HPLC) and Gas Chromatograph (GC), Infrared (IR) and Spectrophotometry; Responsible for the completion of the appropriate documentation, i.e. batch records, engineering tests, validation, production record reviews, investigations and customer qualifications; Responsible for calibration of instrumentation as needed.Administrative Specialist Years Employed: 1997-2001U.S. ArmyType routine correspondence, messages, reports, and forms; serve as receptionist to the Commander, First Sergeant and Operations Sergeant; answer the telephone; handle incoming mail and messages of sensitive nature at times; maintain active and inactive office files for approximately 138 soldiers; use copy and fax machine to relay information through out the installation; receive and maintain policy letter, standard operating procedure logs and additional duty logs; perform daily data entry; supervise young administrative specialist to assist in all daily activities; assisted with financial transactions for soldiers in the unit; processing of awards and evaluations; customer service.Military Police Patrol Officer Years Employed: 1996-1997U.S. ArmyEnforce traffic regulations and law and order; exercise military control and discipline and guard prisoners; responsible for traffic accident investigation; provide physical security for designated individuals, installation, facilities, and equipment; maintain traffic control and enforce traffic regulation and safety; participate in civil disturbance and riot control operations; responsible for law enforcement investigations; perform foot and motorized patrol and apply crime prevention measures; prepare military police reports including sworn statements and processing of evidence; worked with Drug Suppression Team (DST) in order to eliminate drug use on the installation. |
