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Online Resumes with "fda "
System Administrator - 20 Years of Experience - Near 46038
Personal Summary: Successful information technology professional with diverse and extensive experience focusing on security, audit, DISA, installation, testing, patching, upgrading, troubleshooting, support, and maintenance of LANs/WANs, platforms, Unix, Linux, Novell, client, mobility, documentation and systems migration. Strong ability to communicate with clients, management and peers to deliver high-quality systems. Succ...
Tags for this Online Resume: Veritas, Accenture FOUNDATION, Integrate, Local Area Network, Novell, Novell Netware, SAN (Storage Area Network), Troubleshooting, Virtualization, Router, it jobs, linux
Chemical Equipment Operator
PROFILE Accomplished Chemical Operator/Compounder with extensive experience in a high output manufacturing environment. Knowledgeable on all aspects of Current Good Manufacturing Practices (CGMP), Standard Operating Procedures, OSHA and FDA standards. Adept at working within large departments of leading international companies. Recognized for team building abilities. Thrives in a fast-paced environment. Quickly assimilates ...
Tags for this Online Resume: Chemistry, Plating, Consumer Products, Fast-paced Environment, Good Manufacturing Practices, Lotus, Lotus Notes, Manufacturing, Microsoft, Microsoft Excel, steel, mechanical engineer, "project management", reliability, electrical engineer, maintenance, machine operator, die cutting
Quality Engineer - 15 Years of Experience - Near 28013
Summary Profissional with management expertise in engineering, processes, industrial and building maintenance. Supervisory and managing team such as civil, mechanical, electrical, instrumentation, automation and process, evaluation and administration of professional development team. Experience and industrial management in facilities such as steam generation, HVAC, chillers, water treatment and effluent waste treatment stat...
Tags for this Online Resume: Texas Instruments, Utilities, Waste Treatment, Water Treatment, ASME, Automation, Automotive, CAD Tools, Consulting, Engineering, manufacturing, mechanical engineer, production, reliability, maintenance, "project management", Industrial Engineer, Engineering manager
Quality Assurance Specialist - 14 Years of Experience - Near 34685
Summary of Qualifications Over eleven years in a regulated environment including custom built applications, clinical based computer systems, IVRS systems, and data acquisition systems. Seven of those years in an IT management role. Successfully lead teams in promoting quality assurance throughout the software development life cycle (SDLC), both Waterfall and Agile/SCRUM methodologies. Successful in the development and imple...
Tags for this Online Resume: Architect, Project Management, Consulting, Quality Assurance, Software Testing, Systems Engineer, Test, Training, Account Management, sql, agile, html, software, requirements management, requirements gathering, change control, configuration management, project management, audit, management, SDLC, waterfall
Clinical Research - 9 Years of Experience - Near 38654
Career Summary Pharmacovigilance Director of consumer care division with an in-depth knowledge of Food and Drug Administration (FDA) regulations governing the reporting of adverse events and experienced in a GMP, compliance-driven environment. An articulate and positive communicator with proven effective management of staff, workload, vendors and associated processes to maintain exceptional quality, consistency and complian...
Tags for this Online Resume: Documentation, Management, Regulatory Affairs, Compliance, Integrate, Outsourcing, Quality, Risk Management, Triage, Audit, pharmaceutical, regulatory, Drug safety, clinical trials, research
Microbiologist - 20 Years of Experience - Near 80503
Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...
Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing
Mechanical Engineer - 13 Years of Experience - Near 46037
To seek a position in a work environment that rewards performance while contributing to the growth and success of the organization. To obtain a position that will provide the ability to apply my management/leadership skills, communication and relationship skills, my ability to lead by example while mentoring employees and encourage individual growth, to meet project objectives and deliverables while maintaining a productive...
Tags for this Online Resume: plastic injection molding, Project Manager, Mechanical Engineering, SAP, Validation/Verification Testing, Project Leader, Manufacturing, GD&T, electronic packaging, IQ/OQ/PQ, Michigan, FDA, ERP, Supplier Relationship, RFQ, MS Project, DFMEA & PFMEA, Pro Engineer
Director, Medical Device/ Pharma - 15 Years of Experience - Seattle or Bay area opportunities
SUMMARY OF Senior Management, International Experience, Direct Report to CEO QUALIFICATIONS 15+ years in Management with 6+ years direct report to CEO. Built Healthcare R&D at an Applied Material Research Institute from ground zero to 40+ staff, mostly with Ph.D.s. Road mapping Institute's core platform technologies from conception, leading to new inventions, corporate licensing and product commercialization. Managed 30+ he...
Tags for this Online Resume: Insulin, Research, Biomedical Industry, Manufacturing, Management, API, Chemistry, Critical Care - Vascular, Research and Development, nanotechnology, surface chemistry, P&L, platform technologies, material science, Group leader, Department head, medical device, pharmaceuticals, skincare, tissue engineering, implants
Quality Engineer
Tags for this Online Resume: Assessments, Audit, Quality Assurance, SAP, Support, Technical Support, Troubleshooting, Complaints, FDA, Compliance, SOPs, Document Change Control
Mechanical Engineer - 19 Years of Experience - Near 45039
SUMMARY * Strong expertise in System Engineering, Mechanical design, FEA & Vibration testing * 19 years of industry experience in product development and project management * Medical device design experience familiar with ISO13485 and FDA 21 CFR 820 Standards * Extensive knowledge of electro-mechanical, fluid mechanics and heat transfer * High-level in multitasking using communication, presentation, and management skills * ...
Tags for this Online Resume: Management, Project Management, System design, Systems Engineer, HVAC, Engineering, MEMS, Research, Instrumentation, Legacy
Business Analyst - 8 Years of Experience - Near 90503
Summary * 8+ years of experience as a Business System Analyst/Data Analyst in industry domains including Mortgage, Capital Markets, Wealth Management, Retail Banking, e-Commerce and Insurance. * 3+ years of experience in Guidewire Policy Center and Guidewire Claims Center for Property & Casualty Insurance. * Strong understanding of Retail Banking, including Credit Card, Mortgage, Account Transactions, Wire Transfers, Bill P...
Tags for this Online Resume: Microsoft Visio, Unified Modelling Language, VISIO, Agile, Management, Oracle, Business Requirements, Integrate, Quality, Email
Biologist - 15 +Years of Experience - Near 33759
PROFESSIONAL PROFILE Solid experience in QA Regulatory Compliance world class companies. Interested in a challenging position with focus in QA Systems and Manufacturing operations fields. Broad knowledge in cGMP, ISO, EPA, DOT, FDA, and ANSI ASQC regulations. Working knowledge in sampling, inspection, and disposition processes, SPC, Change Controls, NC/CAPA, Validations, and Calibration systems. Highly organized, enjoy cha...
Tags for this Online Resume: Compliance, Documentation, Packaging, SPC, Test, Management, Quality, Quality Assurance, Quality Management, Assessments, pharmaceutical, sap, protocol, SOP, Validation, NC, CAPA, Change Control, Regulatory, Audit, GAP Assessments, Calibration, Raw Material, Incoming Inspection, Batch REcord Review, Classified Clean Rooms, Investigation Reports, Disposition, REserve Samples Program
