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Online Resumes with "FDA"
Project Manager- 10 years experience in Oncology
Tags for this Online Resume: Oncology, GU, eDC, FDA, GCP, ICH
Production Supervisor
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices
Mechanical Engineer
SUMMARY Results-oriented Engineering Professional, with extensive experience designing and delivering medical, bio-medical, and scientific diagnostic instrumentation to achieve overall business objectives. A clear communicator, that is flexible and adaptable, with the ability to work effectively across organizational lines to deliver projects on schedule. A seasoned engineer and project manager, with the expertise to develo...
Tags for this Online Resume: Drafting, Engineering, Instrumentation, ISO, ISO 9000, Manufacturing, Manufacturing Engineering, Reviews, Support, Surgical
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Director of Quality - 20 Years of Experience - Near 60064
Tags for this Online Resume: Global, Leadership, Operations, Fiscally responsible, Compliance, HACCP, GFSI, FSMA, FDA
Business Systems Analyst
Summary Jim possesses excellent analytical and problem solving abilities with strong interpersonal and communication skills. Fifteen years of experience in developing and supporting GxP applications in highly regulated environments, provides him a clear understanding of how FDA and Quality Regulators, look at documentation and process controls. He brings accountability, integrity and a dedication to quality standards, to th...
Tags for this Online Resume: Budgeting, Integrate, Management, Planning, Quality, Quality Assurance, Quality Management, System Integration, Systems Analyst, Applications
Not Listed - 20 Years of Experience - Near 91740
SUMMARY An analytical and detail-oriented healthcare professional, with extensive experience in nursing, biotechnology, regulatory compliance, global safety, pre- and post-market studies, research and development, clinical trials and FDA compliance. Utilizes exceptional organization and communication skills to consistently set and meet high-quality standards. Possesses a proven ability to utilize a cross-functional skill se...
Tags for this Online Resume: Complaints, Coding, Compliance, Manufacturing, Medical, Oncology, Pharmaceutical, Policies and Procedures, Quality, Quality Assurance
Clinical Research - 1 Years of Experience - Near 55102
Tags for this Online Resume: Device and pharmaceutical research, Clinical Research, 21CRF, Preclinical Research, ACRP, ISO 9000, FDA, GCP, Patient Care
Clinical Research - 15 Years of Experience - Near 92880
ACCOMPLISHMENTS * Worked with 50 different sponsor and CRO companies on various GI studies * Managed Bunion investigational study with 300 patients. * Three FDA audits without 483. * Met all recruitment targets within required study timeframe * Managed regulatory binder for studies, post start-up * In depth knowledge of Microsoft packages ( Word, Excel and power point) Experienced with Oracle, Inform, Medidata eDC programs ...
Tags for this Online Resume: Clinical Research, Oncology, Research, Computer Aided Software Engineering, Good Clinical Practices, Medical, Microsoft, Microsoft Excel, Microsoft PowerPoint, Microsoft Word
Quality and Regulatory Compliance
SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...
Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services
Product Design Engineer - 17 Years of Experience - Near 19335
Professional summary: * Graduated Magna Cum Laude from Rensselaer Polytechnic Institute (Troy, NY) B.S. in Mechanical Engineering (BSME). * 20 years of product development experience. For the last 14 years, served as a primary developer and engineering lead. Main focus on innovation, quality and value. * Excellent CAD skills (SolidWorks), GD&T, FEA. * Multidisciplinary career, spanning fields of Medical Devices, Defense, Op...
Tags for this Online Resume: Philadelphia, Research and Development, Product Design, Firearms, Medical Devices, Optics, Electronics, Engineering, Injection Molding, Lean Manufacturing, Machining
Not Listed - 20 Years of Experience - Near 94704
Professional Profile Pg 3 of 3 Hanan Altschuler, Machine Builder/Technologist - Process / Mechatronics Engineer P. O. Box 265, Berkeley, CA 94701 Forensics / Productivity and Quality / Validation E-mail: hanan@lmi.net Other Specialized Experience: * Use of multi-disciplinary approach to design products incorporating optical, mechanical, electrical, chemical, biological, and other technologies in a single product with compli...
Tags for this Online Resume: ANSI, quality, Automation, Automotive, CNC, Compliance, DFS, Documentation, Engineering, Failure Analysis, R&D, industrial design
