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Click here or scroll down to respond to this candidateCandidate's Name
Email: EMAIL AVAILABLEPhone: PHONE NUMBER AVAILABLEEXPERIENCEExperience with Class II and Class III medical devices/drugs of interestConducting compliance audits of complex documentation and data.Administration, filing, maintenance, retrieval, issuance, and destruction activities.Experience following GLP, GMP, and QSRs guidelines identifying and initiating CAPA activities investigation (deviations, documentations).Class II (510) K and Class III PMA medical device submissions experienceFamiliar with US and International regulatory standards for medical devices.Reviewing and assessing change control, validation and qualification documents.Skilled in making experimental observations, decision making, providing effective solutions, and organizational management.Extensive medical education in basic medicine, heart failure, and kidney disease.Molecular Biology techniques involved in biological testing and research.Biocompatibility testing of raw materials and finished products for medical devices such as LAL, endotoxin, sterility, pyrogen, and cell culture.SPECIAL INTEREST AND RESEARCH(510), PMA submissions of class II and III medical devices to FDA.FDA regulatory standards, QSR, 21 CFR 830, ISO 13485.Molecular, Biological research and techniques.Biocompatibility testing.Cell Culture laboratory experience.Quality Control inspection for medical devices and pharmaceuticals.Quality Assurance Analysis.Smart Scope Vision System, CMM Instruments for Precise Measurements.Clinical trial studies.PROFESSIONAL SUMMARYExtensive medical device, drugs clinical research and molecular biology background characterized by discipline and leadership.Cell culture experience with mammalian cells, and stem cells.Writing clinical study protocol.Skilled in making experimental observations, decision making, providing effective solutions, and organizational management.Medical Device Rreporting (MDR) and Adverse Drug Report (ADR).Experience with Class II and Class III medical devices/drugs of interestExpertise with medical devices and pharmaceutical drugs clinical studies which include: IDE, PMA, 510(K), CE Mark, international and US regulatory submission requirements, site selection, monitoring, auditing, IRB, CRO and FDA.Extensive cell culture work experience. GMP, GLP certified.Laboratory research and protocol writing experience.Molecular Biology Techniques expertise in mammalian cell culture.PMA clinical trials submission to FDA medical device class III Drug Coated Stent.Strong computer skills with proficiency with MS Windows Office based applications.Molecular Biology techniques expertise, PCR, DNA extraction and data analysis.Supervisory and managerial experiece.EXPERIENCEQuality Inspector III, Structural Heart, Abbott Laboratories, Plymouth, MN3/2022 3/2024Provide manufacturing support by reviewing and analyzing returned devices data to determine manufacturing issues and trends.Train operators on processes and engineering changes and perform operator certification on-the-job training and testing.Identify, resolve and prevent potential Manufacturing issues by assisting in the determination of root cause and implementing corrective and preventative action; support activities to track complaint product returns.Review and evaluate dispositions returned devices non-conforming material by utilizing quality tools and by developing knowledge of manufacturing practices and procedures.Identify and resolve systemic issues based on trends noted during review of non-conforming material.Support process development during new product introduction by defining traceability and inspection requirements, developing statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications.Provide input to engineering, qualification, and validation studies and reports by collecting, compiling, measuring, organizing, and recording data, and by writing procedures.Use precision measurement equipment such as Mico-Vu, Tesa-Hite, Zeiss, CMM, for receiving inspections of all parts and materials entering Abbott, before being released to manufacturing.Microbiologist, Biocompatibility and Sterilization Associate Medtronic, Brooklyn Park, MN11/2019 3/2022Worked closely with internal R&D teams and external labs to design biocompatibility assessment strategies.Ensured that adequate documentation existed for all the new and existing products to meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993.Coordinated recommended biocompatibility testing with external research labs, and assessing applicable test data Planning, leading or supporting protocol development, study management, data analysis and reporting of data.Wrote Biocompatibility Assessment Reports.worked closely regulatory affairs, quality engineering, and manufacturing to support projects that need biocompatibility assessments.Understanding of EO residual, EO tolerable contact limit, D-Value, and SAL.Coordinated annual EO sterilization cycle revalidations.Developed and executed product sterilization validations.Coordinated biocompatibility evaluations.Created reports for quarterly radiation dose audits for product families.Managed and coordinated projects with external sterilization organizations.Quality Control Specialist TapeMark St. Paul, MN11/2017 11/2019Responsible for acting consistently with TapeMark values of Excellence, Responsibility, Integrity, Community, Knowledge and Attitude to ensure the organizations effectiveness and success.Responsible for audits and inspection to assure ISO 9001/13485, cGMP, TM and customer requirements are met.Operation of machines in making pharmaceutical drugs.Conduct in process inspections and start up audits to assure manufactured products are conforming to customer requirements.Review operations documentation ensuring compliance with cGMP, ISO 9001/13485, FDA, regulations and customer requirements.Work closely with operation manufacturing records and production batch records to ensure compliance of all regulations.Initiate MRRs and Incidents for non-conforming raw materials and finished products.Verify that all test data is correct, complete, and files are updated with all necessary documentation.Communicate with outside vendors, co-workers, supervisors, managers and other departments about barriers and solutions in a professional manner.Coach operations staff on QA requirements.MDR/Vigilance Specialist contract American Medical Systems (AMS), MN2014 11/2017Participated in developing strategies for regulatory reporting decision using event investigation and regulatory decision models.Completed regulatory reports within the timeframe mandated by FDA.Developed internal systems, methods, and procedures to maintain compliance and support post market surveillance.Evaluated and identified complaints, investigated root cause analysis.Associate Scientist University of Minnesota, Minneapolis, MN2007 2014Performing molecular biology techniques, including DNA isolation from whole blood and buccal cells, sample tracking, the polymerase chain reaction and SNP analysis.DNA genotyping for polymorphisms (SNP) using the polymerase chain reaction, TaqMan analysis and other forms of genotyping.Performed daily microbiology research laboratory testing.Cell culture laboratory tests and maintaining cell viability.Flow cytometry analysis of extracted lymphocytes from blood of patients.DNA extraction from Blood and Saliva used for genotyping in Twin Family Study Research at the Department of Psychology Behavioral Genetics.Maintained cell culture line viability for ongoing research.Clinical Research Associate (CRA), Boston Scientific, Maple Grove, MN2003 2007Involved in on-going Preclinical Research animal studies, focused on treatment of coronary artery disease. Contributed to TAXUS Stent program in Preclinical study trialsMaintained adequate knowledge and understanding of current scientific literature required to support all product lines and related preclinical studies.Served as the Pre-Clinical representative on assigned project teams and participated in team decision making.Provided clinical and preclinical guidance, strategy, and support for the development of new technologies, new products, extended products claim, and pre-clinical foundation research.Morphometry analysis of histology slides.Worked with BIOQUANT medical investigational computer software in image captured measurements and analysis.Tracing IEL, EEL and Lumen of stented coronary arteries (LAD, LCX, RCA, and LCA).Used software BIOQUANT computer to measure the growth percentage (restenosis) of neointimal tissue.EDUCATIONClinical Research Professional (CRP) Certificate2012, Anoka Ramsey Community College Anoka, MinnesotaBachelor of Science, Biology1993, University of Minnesota, Twin Cities.Publication in Journal of Heart Valve Disease. Heart failure and Atrial Fibrillation 2006.Post Graduate Continued Education 2014-2020University of Minnesota: Virology, physiology and anatomy, medical microbiology, immunology, heart failure and atrial fibrillation, Medical device clinical trials Class II and Class III, and Molecular Biology laboratory techniques. |
