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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE CellEMAIL AVAILABLEDynamic Leader with 24+ Years of Experience in Medical Device and Pharmaceutical Industries, Specializing in Risk Management, Validation, and Compliance EXPERIENCEBest Buy Health 08/22-PresentHealth Risk Engineer Manager Leading Risk Management efforts & harmonization of risk management strategies, including training and supporting methodologies and tools Development of the risk management files Champion the Quality culture change across the organization Supporting the implementation of QMS Supporting regulated division with improving the risk management and complaint processes Stretching expertise to assist regulated division to prepare for FDA inspection O&M Halyard 04/17-08/22Technical Quality Leader Development of the Risk Management files which includes Product Hazards Analysis, Design FMEA, Use FMEA & Process FMEA for new products Development of Manufacturing Control Plan Realization documentation Provided technical leadership in solving more challenging technical problems related to quality issues and technologies Developed, initiated, and implemented new quality concepts, tools and strategies to improve business practices Assisted with the transfer of knowledge of technical skills Actively participated in the development of product development plans, specifically components that focus on design reviews, quality plans, design transfer, and design verification/validation Directed all activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety and performance Led the efforts to ensure compliance to all risk management requirements Partnered within cross functional teams to establish root cause and mitigations of product issues during development Actively participated in the development of statistical plans and rationale for design control activities/requirements Actively partnered with the project teams to facilitate the incorporation of all quality system elements, root cause analysis, corrective action, and continuous improvement principles throughout the entire product re-design Supported and facilitated updates to Design History Files (DHFs) Supported the Design Control and Risk Management Quality Systems by leading the activities for the implementation of ISO 14971:2019 Supported critical quality activities, such as internal/external audits, escalation/QRB process, and other RA/ QA activities Supported Design Controls, Risk Management and EtQ DHF & Validation Module by identifying improvements, providing training, and updating procedures Supported QA activities for EUMDR certification, and RA projects: Brexit, PPE Halyard Healthcare 06/15-04/17Quality Specialist Actively participated in and/or facilitate the development of deliverables required for medical device product development Actively participated in the development of product development plans, specifically components that focus on design reviews, quality plans, design transfer, and design verification/validation Directed activities necessary for the project team to achieve design control deliverables Led the efforts to ensure compliance to all risk management requirements Partnered within cross functional teams to establish root cause and mitigations of product issues as they arise during development Actively participated in the development of statistical plans and rationale for design control activities/requirements Actively partnered with the project teams to facilitate the incorporation of all quality system elements, root cause analysis, corrective action, and continuous improvement principles throughout the entire product redesign Supported and facilitated updates to the Design History Files (DHFs) Osmotica Pharmaceutical 04/14-05/15Sr. Validation ScientistRole#1: Equipment Validation Writing validation protocols: Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification, and summary reports Created Risk Assessment, FMEAs Manufacturing Process validation Assisted in revising and completing all required operators instructions, SOPs Role#2: Cleaning Validation Writing all validation protocols, execution, and final reports Created the rationale of matrixing active components for a Worst Case Cleaning Validation Program and understands the rationales for various acceptance criteria for Cleaning Validation limits (e.g. NOEL, 10ppm)OptiMedical 05/12-09/13Senior Validation Engineer Writing validation protocols: Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification, spreadsheet validation, and summary reports Created Risk Assessment, FMEA Process validation, MSA Conducted engineering studies (ES) Participated in the completion of a lean project Assisted in revising and completing all required operators instructions for a new instrument line, SOPs Completed SQL database data transfer qualification Alkermes plc 01/12-05/12Validation EngineerRole#1: Cleaning Validation Writing all validation protocols, execution, and final reports Created a rationale of matrixing active components for a Worst Case Cleaning Validation Program and understands the rationales for various acceptance criteria for Cleaning Validation limits (e.g. NOEL, 10ppm)Role#2: Equipment Validation/Process Writing validation protocols: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification, and summary reports Temperature/humidity mapping of ovens using the Kaye Validator Created Risk Assessment, FMEA.Aerotek 03/10-01/12(Client:Ciba Vision)Senior Validation Engineer Writing validation protocols: Master Validation Plan (MVP), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and summary reports Assisted in the review process of the User requirement specification and Functional design specification documents Created Risk Assessment, QNA, FMEA, and Traceability Matrix (TC) Remington Medical 09/09-03/10Quality Engineer Writing all validation protocols and final reports (ex. Injection molding machines), related documentation, design verification, and statistical process control Writing computer system validation protocols for molding machines Created PVR, design control, Risk Assessment, FMEA, Test Method Validation, and Gage R & R for manufacturing equipmentTech USA 11/08-09/09(Client: BD Lee Laboratories)Equipment Validation Engineer Writing all validation protocols (Process PQ, IO, and OQ), and final reports, related documentation, statistical process control Created Risk Assessment, FMEA, safety assessment, Gage R & R, and control plans for manufacturing and packaging equipment Temperature mapping of incubators, refrigerators, and nitrogen tank using the Kaye Validator PharmaSys, Inc. 10/07-02/08(Client: Leiner Health ProductsEquipment Validation Consultant Writing all validation protocols including IQ, OQ and PQ Assisted in creation of Equipment Files for packaging machinery Created site validation plans and specific project plans for equipment and utilities Oversaw equipment and utility validation activities Leiner Health Products, Fort Mill, South Carolina 3/00-2/07 Validation Senior Specialist IIIRole# 1: Process Validation Writing all validation protocols and final reports, related documentation, statistical process control, capability studies and employee training Product Mix included ANDAs, Monograph and Rx to OTC switch Responsible for physical sampling and testing for bottle and blister validation including Leak Testing, Fill Count, Child Resistant testing, torque testing, etc. Performed physical sampling and testing for Process Validation samples including blends, compressed tablets and coated tablets. Responsible for RO/DI & USP Water sampling, which included microbial, coliform, TOC and conductivity collection.Role# 2: Cleaning Validation Writing all validation protocols, execution and final reports Assisted with support procedures for current product line, training, and revalidation of cleaning procedures Created a rationale of matrixing active components for a Worst Case Cleaning Validation Program and understands the rationales for various acceptance criteria for Cleaning Validation limits (e.g. NOEL, 10ppm)Role# 3: Package Validation Writing all validation protocols and final reports, related documentation, statistical process control, capability studies and employee training Product Mix included ANDAs, NDAs, Monograph and Rx to OTC switch Implemented Matrix approach to reducing bottle and cap complexity for the packaging lines Led the department in issuance of Validation Parameters to the batch records for process control of the packaging line Supported large Package Validation projects while meeting all customer expectations with limited resources in a timely manner Blister and Bottle Package Validation Writing and conducting equivalency runs for equivalent proposed components and for Stability packaging RunsRole# 4: Equipment Validation Writing validation protocols including IQ, OQ and PQ Worked on extensive projects that included NIR for the QA lab in both Fort Mill and Garden Grove facilities, Anatel TOC meter, Bellatrx Bottle Recovery System Additional equipment included Solid Oral Dosage Equipment: Blenders, Compression, and Coating. Packaging Equipment: Bottling and Blistering Lines Conducted overseas and local Factory Acceptance Testing for new Equipment for Packaging supported a large volume of equipment transfersEDUCATION May 1999, University of Texas, Bachelor of Science Degree in Chemistry, Dallas, Texas ADDITIONAL TRAINING Visio 5.0 Basic Skills- Presented by Computer Training UnlimitedJuly 2000. Failure Investigation-Presented by David M. Dimmick-QA/GMP Compliance Consultant-Jeff Yuen and Associates-December 2000. IVT Annual Meeting: Validation WeekPresented by IVT November 2002. The Technical Writing Workshop- Presented by Rockhurst University Continuing Education Center-May 2002. Team Based Organization Training- Presented by John McWhorter-March 2003 FT-NIR, AssureID Software and Quant Training on Site (Garden Grove, CA)-Presented by Sam White-June 2004 Key Aspects of a Process Validation Program-Prerequisites and Regulatory Expectation-Presented by Miguel Montalvo-February 2005. Root Cause Analysis, Understanding Failures, Exceptions, and Non-conformances-Presented by Lee N. Vanden Heuvel (ABS Consulting)-February 2005 Microbiological Aspects of Cleaning Validation-Presented by William E.Hall-March 2005. Cleaning and Cleaning Validation, A FDA Hot Button-Presented by William E. Hall-March 2005. Conflict Management Skills for Women-Presented by Rockhurst University Continuing Education Center-September 2005 Basic Supervision- Presented by Rockhurst University Continuing Education Center-April 2006 How to Conduct Internal Investigation-Presented by Steve Hewitt-May 2006 Lean Six Sigma, for Manufacturing and Business Processes, Control, September 2012 Lean Six Sigma, for Manufacturing and Business Processes, Lean Techniques, March 2013 Lean Six Sigma, for Manufacturing and Business Processes, Measurement System Analysis (MSA), April 2013 Design for Six Sigma (DFSS), March 2016-July 2016 Internal and external audit lead Project Management- MS Project First of a series on the Medical Device Risk Management Standard ISO 14971:2019, ISO TR 24971:2020, and equivalent EN versions By Edwin Bills, Member ISO TC 210 JWG1 |
