Fabiola Valverde

Fabiola Valverde Angulo Jr. Microbiology Engineer Dedicated CER Specialist professional with 7+ years of experience and history of exceeding company goals utilizing consistent, organized and outstanding attention to detail practices while implementing exceptional team leadership best practices. Skilled in working under pressure and adapting to new situations and challenges while being able to amplify company savings with an estimate of over $165K+. Work History Jr. Microbiology Engineer 2022-06- current Smith & Nephew • Implementation of “Endotoxin In House” department project, to avoid payment to external supplier, saving up to $520k. • Responsible for reviewing and approving the results reports of the environmental monitoring of Controlled Rooms. • Responsible of training laboratory technicians in product analysis. • Supports execution and maintenance of environmental monitoring program including the coordination of cleanroom certification and associated personnel qualification. • Performs Out of Tolerance investigations (OOT) for microbiology equipment according calibration requirements procedure. • Executes, maintains, and improves microbiological testing on finished products (implementation, development and validation of testing methods such as bioburden, sterility, bacteriostasis & fungistasis, and endotoxin testing) • Support the development of standard operating procedures, work instructions, test procedures, and verification/qualification protocols for products, materials, and equipment testing. • Collaborate in CAPA and NC investigation to determine root cause and appropriate correction/corrective actions when out of specification results for microbiology testing are obtained. • Knowledge and understanding of quality system regulations/requirements (i.e. ISO 11137, ISO 13485, ISO 11135, ISO 17025, 21 CFR Part 210/211, Part 820, and cGMP/GLP and USP. Responsible for approving work or new equipment/tools in controlled environment • areas. • Generates and reports trend analyses for environment and product test results Clean Room Specialist- – 2022-05 Smith & Nephew • Overseeing of air, surface, product, clean room and laminar flow chamber working on 700+ ongoing monitoring necessities enabling savings to company and ensuring that company is complying with market and future audit guidelines. • Recognized for controlled rooms environment shut down leadership and coordination of 3consecutive day monitoring by strategically delegating shut down functions to 4 employees while providing organizational report to department manager ensuring all shut down activities are covered and supported, successfully completing activities by 100% meeting all required guidelines without resourcing to extra time nor delivery delays. • Implementation of "Bioburden in House" department project to avoid payment to external supplier for performing of Bioburden test saving up to $165k, exceptional performance on entire company inventory validation and end-to-end product dry runs testing ensuring ultimate acceptable technique and process to ensure ultimate approval. • Prepare reports and trend charts for data monitoring. • Leadership of entire endotoxin process, in charge of shipping up to 130 samples that need to be tested, then devoted to receiving ultimate result reports and spearheading eventual product approval and releasing if these meet the required guidelines. Laboratory Technician 2017-06 - 2018-11 Microbiología y Calidad Industrial MCI • Conducted air, alcohol, surface and water testing for up to 15+ company clients performing these successful testing practices monthly enabling clients to comply with FDA and/or other guidelines while amplifying company revenue. Contact Address Alajuela, San José Phone- E-mail- Skills Risk management - Process engineering - Hazardous materials - Quality guidelines compliance – Product Knowledge- Process management - Crossfunctional team collaboration – effective communication- Team leadership - Function delegation - Attention to detail – NegotiationDeductive reasoning Efficiency and accuracy – Compromise- Quality system regulation- ISO 13485 - ISO 17025 Software G-Suit – Microsoft Office – Minitab- Project Languages Spanish native and English proficiency. Certifications BET: Endotoxinas bacterianas y la prueba de pirógenos Habilidades blandas y trabajo en equipo Validación de Métodos de Ensayo - Conceptos básicos de la Norma INTE-ISO/IEC 17025:2005 - Estimación de la Incertidumbre de la medición. - Técnicas Asépticas y manejo adecuado de desechos • • Performed 15+ monthly accurate internal testing for endotoxin that analyzed up to 70+ medical devices, developing results reporting while working in conjunction with crossfunctional teams assuring clients that their devices were complying with permitted endotoxin limits enabling the clients’ products to be sold, due to this testing and analysis the company was able to perceived a revenue of over $3K+. Completed 4+ investigations and root cause analysis of non-conformity testing situations keeping track of steps performed during the process and identifying contamination issues, this way avoiding overwork and resource waste while being recognized for identifying corrective actions that generated savings for the company of up to 30%. Histotechnologist 2017-05 - 2017-12 Hospital San Rafael de Alajuela • In charge of processing all specimens received in the Histology laboratory. Histotechnologist 2017-01 - 2017-04 Hospital Mexico • In charge of processing all specimens received in the Histology laboratory. Laboratory, Auditor and Quality Coordinator 2014-08 - 2016-11 Juturna S.A. (Waterlab) • In charge of acting as point of contact to search for Chemical Regent who would be in charge of laboratory regency for needed company audit being able to meet all quality and audit guidelines. • In charge of attending 4 external audits from Ente Costarricense de Acreditación ECA to comply with ISO/IEC 17025. • Oversaw accurate completion of multiple chemical and water related analysis being able to deliver up to 300+ monthly analysis enabling corrective actions for clients and amplifying company revenue through product sales for over $20K+. • Give support to the sales department to give the best equipment option to the client and finalize the sales and meet monthly sales goals. • Conducted end-to-end quality system for the entire laboratory by organizing documentation, inter-laboratory practices, reports, among others while in charge of constantly auditing water testing practices are compliant with general guidelines by mentoring 7 laboratory technicians, recognized for exceptional management and maintaining compliance results of over 97%. Education Licenciatura Industrial Chemistry 2020-01 – Ongoing. Universidad Latinoamericana De Ciencia y Tecnología. Diploma – Histotechnology. 2015-07 - 2018-06. Colegio Universitario Iparamedica Professional incorporated to Colegio de Médicos de Costa Rica. Tec 6233 Diploma – Chemical Laboratory worker for Quality Assurance. 2013-02 - 2014-06. Universidad Técnica Nacional sólidos hospitalarios – Fundamentals of Industrial Sterilization.