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Online Resumes with "FDA "



Vice President

SUMMARY: A strong combination of technical knowledge and operations leadership built from 20+ years working in the food manufacturing industry in various roles with progressive responsibilities with emphasis on safety, food safety, increasing efficiency and developing teams.

Tags for this Online Resume: EH&S, Inventory, Manufacturing, Documentation, Inventory Control, Purchasing, Quality, Biomedical Industry, Training, Utilities, SQF, FDA, Chocolate, kaizen events, 5s, Coaching, Right First Time

Production Manager - 20 Years of Experience - Near 77079

for repair business of set top boxes while at Jabil * Management in excess of 500 people thru his direct reports Multilingual Dutch, German, Spanish and English fluent. * Q.S 9000 Certification from TRW (writing of work instructions) * D.O.D. experience from Manconix, Inc. * Worked with FDA at J & D Produce, Inc. * Proven experience with FIFO and lot control * JIT and E-Kan Ban expert * O & G Experience Compensation: Open H...

Tags for this Online Resume: Logistics, R3, SAP, SAP R3, Automotive, Language Skills, Microsoft Visio, Pc, Personal Computer, Purchasing

Biomedical Engineer - 2 Years of Experience - Dallas

SUMMARY: Biomedical Engineering graduate student with a specialization on Medical Imaging and Instrumentation. Hands on experience in operating complex medical equipment and expertise in image processing. IISE Certified Six Sigma Green Belt. Knowledge of ISO 14971, ISO 13485 and FDA regulations. Independent researcher, Dedicated, Self-Driven, Self-Motivated, Result Oriented, Team Player, Detail Oriented, and a Quick Learner.

Tags for this Online Resume: Data Analysis, Matlab, Biomedical Industry, C Programming Language, C++ Programming Language, Connectivity, Engineering, Green Belt, Image Processing, Imaging

Program Manager - 16 Years of Experience - Near 94598

Accomplishments * Lead technical support and infrastructure personnel as well as business users in design, delivery, and security of a major ERP application * Successfully managed consolidation of 3 separate ERP (JDE) programs into a single instance JDE ERP, creating more efficient business framework and improved collaboration among global Sales, Manufacturing, Finance, and Distribution operations in nine EU countries * Arc...

Tags for this Online Resume: Management, MIS, Project Management, Project Manager, J.D. Edwards, Program Manager, Amazon Web Services, Backbone, Distribution, e-Commerce

Microbiologist - 20 Years of Experience - Near 45066

Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...

Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures

Chemist - 7 Years of Experience - Near 01603

SUMMARY OF EXPERIENCES & SKILLS: * Nine years of experience in Biochemistry. Primary area of expertise is HIV/AIDS research. * Very good familiarity with and certification in Good Clinical Practice (GCP) Familiarity with US FDA and EMEA guidance on clinical research * Master's degree work on determination of Human Immunodeficiency Virus-1 serotypes * Other areas of expertise include molecular biology, immunology, organic ch...

Tags for this Online Resume: Clinical Research, Electrophoresis, ELISA, HIV, Research, Budgeting, Financial, Financial Management, Inventory, Inventory management

Quality Manager - 20 Years of Experience - Near 30152

Known as a Quality and Operations Leader for improving business results and promoting the quality approach to doing business by example. I believe everyone has a customer and a supplier regardless of their function in the organization. * Led the effort at both Ampac and Printpack in developing and implementing a corporate-wide management system based on the ISO 9001 ISO 13485 ISO 14971 ISO 11607 as well as other FDA EU and ...

Tags for this Online Resume: Pharmaceutical, Manufacturing, Management, Process Improvement, ISO 9001, Product Development, Purchasing, Continuous Improvement, Quality Assurance, ISO 13485, Lean Methods, Six-Sigma, Corrective Action, CAPA, Root Cause Analysis, Package Manufacturing, Quality Management, Training Management

Pharmacist - 13 Years of Experience - Near 33785

SUMMARY: * Active Florida Pharmacist License #53616 * Highly knowledgeable with experience in prior authorization, hospital, retail and long-term care pharmacy. * Adept at all aspects of daily management and inventory * Strong decision-making ability * Efficient and accurate * Skilled in clinical interventions * Strong clinical background * Drug utilization review * Inventory management * Expert understanding of Medicare an...

Tags for this Online Resume: Management, Triage, Nephrology, Cardiovascular, Data Management, Research, Sales, Sales Training, Training, Clinical Research

Clinical Research - 10 Years of Experience - Near 18901

Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...

Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development

Operations Manager - 16 Years of Experience - Near 10032

Managed Managed the logistics and traffic operations for the liquid sugar, bulk sugar, and sugar mixing operations in three warehouses- two in cost effectiveness and control efficient production procedures and compliance with standard food safety procedures the three warehouses. * Monitored inventory levels in the three locations to ensure efficient production shipping and customer fulfillment - always exceeding customer ex...

Tags for this Online Resume: Audit, Documentation, Settlements, sheets, Transportation, Vendor Invoices, Vista, Commercial Loans, Logistics, Supply Chain

Training & Development Manager

Accomplishments and Related Skills: * Responsible for the administration, evaluation, and improvement of the American Medical Informatics Association's Continuing Educational (CE) programs * Planned, developed, implemented, and evaluated Continuing Education (CE) programs for Continuing Medical Education (CME), Continuing Pharmaceutical Education (CPE), and Continuing Nursing Education (CNE) * Utilized adult learning theori...

Tags for this Online Resume: Compliance, Evaluate, Management, Medical, Services, Training, Instructional Methods, Nursing, Pharmaceutical, Planning

Biomedical Engineer

SUMMARY * Extensive experience in the Pharmaceutical, Biomedical, and Semiconductor industries. * Well rounded Engineering and Business experience in Project and Operations Management, Quality Assurance, Applications, Equipment, Process, and Electronics Engineering. * Data driven, results-oriented, team-builder who strives to make significant, measurable contributions. * Thrives in complex, cross-functional, and dynamic env...

Tags for this Online Resume: Cardiopulmonary resuscitation (CPR), Diagnostic Imaging, Distribution, First Aid, Imaging, ISO, ISO 9001, Medical, NRC, Nuclear Medicine