CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "21CFR"

Electrical Engineer - 11 Years of Experience - Near 10930

Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...

Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery

Laboratory Manager - 18 Years of Experience - Near 28037

Qualifications Summary Laboratory Manager with extensive experience in regulated pharmaceutical manufacturing and research and development with more than 10 years of management experience. Thorough understanding of regulated Laboratory environments including but not limited to GMP, GLP, GDP and 21 CFR Part 11. Quick learner with proven track record of driving success. Skilled at navigating FDA and vendor audits. Implemented...

Tags for this Online Resume: Project Leader, Project Management, Budgetary, Drafting, High Performance Liquid Chromatography (HPLC), Management, Planning, Rational, White Papers, clinical, phase, trial, gcp, protocol, pharmaceutical, Quality, LC/MS

Life Scientist - 20 Years of Experience - Near 02642

SUMMARY IT/QA PROFESSIONAL Biotech - Pharmaceutical - Medical Device - Life Sciences Highly skilled consultant and Project Manager with diversified domestic and international experience and a background that incorporates strong technical orientation with business skills. Hold proven record of success in product development, process improvement, cGMP compliance, validation and quality control. Examples: * Software Implementa...

Tags for this Online Resume: Software, Compliance, HVAC, Management, Support, Assessments, Automation, Integrate, Manufacturing, Millenium (Sw-Fin/Admin), gcp, pharmaceutical, sas, protocol, clinical

Quality Assurance Specialist - 13 Years of Experience - Near 08540

Professional Summary More than 14 years of experience in Pharmaceutical and Life Sciences Industry with key focus in Business Requirements Analysis Data Analysis and Management Software Application Testing Document Management Change Control and Release Management FDA Compliance Verification and Validation Quality Assurance Processes and Methodologies Developing Testing Strategies and Test Plans Test Scenarios and executing ...

Tags for this Online Resume: Test Scripts, Test, Management, Test Cases, Structured Query Language, Audit, CFR Part 11, Test Plan, Application Server, Documentation, validation of protocols

Quality Assurance Specialist - 6 Years of Experience - Near 75093

SUMMARY * Experienced with Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). * Experienced in Agile and Waterfall environments. * Experienced in using HP interactive products like -HP Quality Center (ALM/QC) and JIRA. * Good exposure to Web technologies like HTML, XML and JavaScript. * Experience in SQL queries and Joins (Inner/Outer) to validate data. * Experience in IVR/IWRS Testing. * Experie...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server, sql, java, javascript, agile, html, software

Computer Programmer - 20 Years of Experience - Near 33156

Hi, I wrote the BEST GUI for Angular 2 Mobile App Frame called SwipeClouds that is SUPERIOR to Ionic – Read My Article About It: https://www.codeproject.com/Articles/1175045/Angular-Mobile-App-with-JQuery-Mobile-Cordova-or-P Previously I developed software for Microsoft as their Director of Live Search Marketing & Software Development. And at MySpace.com I was their Director of Software Development. I work with the lates...

Tags for this Online Resume: jQuery, Microsoft, Microsoft Windows, Blackberry, Hyper Text Markup Language 5, Marketing Management, Project Leader, Video, Security, Software, linux, it jobs, c++, html, agile, c#, software, javascript, java, sql, PhoneGap, HTML5, Angular, Angular4, Angular2, Angular 5, JQuery, Mobile, Java, Objective C, SwipeClouds Framework, Canvas, CTO, Director, .NET, VB .NET, Angular 1.4, React

Electronics Engineer - 20 Years of Experience - Near 30054

Areas of Expertise: * Design for Serviceability * Design for IEC 60601 EMC COMPLIANCE * Design for IEC 60601 SAFETY Compliance * Design for Manufacturability * TRANSITION OF PROTOTYPE DESIGNS TO MANUFACTURING * Analog, Digital & Power Circuit Design * 21 CFR 820 * PCB DESIGN * Research * Hands-on Prototypes * Cross-Functional Teams * ENGINEERING PERSONNEL MANAGEMENT * ISO 9001 * CLASS II AND III MEDICAL DEVICES

Tags for this Online Resume: Rf, Compliance, EMC, System design, Analog Design, Electronics, Magnetic Resonance Imaging (MRI), Research, Networking, Product Development

Supervisor

Mr. Thomas M. Golden is a Senior Validation Engineer with 25 years of experience in the pharmaceutical and biotech industries. Mr. Golden has extensive experience in both management and team player roles in utilities process development scale ups technology transfer cGMP GDP SOPs FDA regulations and critical utilities. He has excellent oral and written communication skills and is an innovative leader who believes in teambui...

Tags for this Online Resume: Manufacturing, Procurement, Utilities, Packaging, Protocol, Acceptance Testing, Management, Pharmaceutical, manager

Production Manager - 20 Years of Experience - Near 32825

PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...

Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management

Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry

PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...

Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device

Chemist - 20 Years of Experience - Near 84341

Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...

Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface

Quality Manager - 20 Years of Experience - Near 37064

Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...

Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions