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Online Resumes with "FDA"



Quality Assurance Specialist - 7 Years of Experience - Near 55446

SUMMARY: * Around 7 years of experience in Software Testing in Web based Application, Insurance, Healthcare and Banking Applications. * Proficiency in defining, formatting and executing Test Cases based on Business Requirements Ensuring the Traceability for the requirements throughout the testing process. * Good knowledge with Medial Devices (such as ISO13485 standards, IEC60601, FDA processes such as PMA, 510k, Validation ...

Tags for this Online Resume: Java Programming Language, Test, Test Cases, Microsoft Windows, Structured Query Language, Management, Regression Testing, Test Plans, Acceptance Testing, Agile, sql

Research Assistant - 1 Years of Experience - Near 28273

SUMMARY OF QUALIFICATIONS: * Experience and in depth knowledge of cGMP, FDA regulations, MSDS and NFPA, aseptic techniques, and batch processing * General knowledge of entry-level process technician in bioprocessing, pharmaceutical, and chemical manufacturing * Hands on experience in analytical/laboratory methods * Hands on experience with routine urine specimen collections * Experienced in blood drawing procedures to inclu...

Tags for this Online Resume: Phlebotomy, Venipuncture, Documentation, Policies and Procedures, Benefits, Financial, Medical, Microsoft, Microsoft Office, Microsoft Windows

Supply Chain Manager - 20 Years of Experience - Near 55337

I am a Logistics professional who is capable of managing logistics, supply chain, regulatory concerns and operations functions by utilizing a variety of resources. My expertise is in executing any and all tasks presented and necessary to successfully maintain high customer satisfaction expectations. Through my comprehensive history of increased professional scope and skills learned, I am thoroughly prepared for any logis...

Ideal Companies: Cargill, UTC Aerospace Systems, General Mills

Tags for this Online Resume: Logistics, Supply Chain, International Trade, Import / Export, Air Freight, Ocean Freight, Transportation, SAP, JDE, OTM, Freight, Microsoft Office

Director - 10 Years of Experience - Near 92503

QUALIFICATIONS: Lean Black Belt Trained, Performance Management, Team Building, Interpersonal skills, Leadership, Budget Management, Commercial/Big Box retailer, Change Management, Communication, Decision Making, Planning, Organizing, Information Systems, Kiazen/Lean, A3, 5S, Six Sigma, KPI's, ISO 9000/13485, FDA and cGMP, Verbal, Written, Presentations, Motivator, Quality & Regulatory & Environmental Compliance, Environmen...

Tags for this Online Resume: Supply Chain, Inventory, Profit & Loss, Satellites, Test, Training, Weapons, Aerospace, Apple, Automotive

Quality Engineer

PERSONAL SUMMARY Highly effective and result oriented Certified Quality Engineer and Mediator with many years experience in manufacturing, First Article, Secondary Labeling, Equipment Testing, Document Control, Work closely with Abbott Laboratory Diagnostic Manufacturing Company Research & Development to identify and evaluate products for market launch. A process-oriented and, results-driven Quality Control Auditor 2 year w...

Tags for this Online Resume: manufacturing, mechanical engineer, "project management", Compliance, Audit, Complaints, Management, Home Health, Nursing, Policies and Procedures, production, reliability

Quality Engineer - 15 Years of Experience - Near 10312

Summary of Qualifications * Provide validation services for pharmaceutical clients to be compliant with FDA regulations utilizing CSV methodology * Professional with a strong background in validation, quality, information technology, and chemistry domains for pharmaceutical and medical device industry * Proven knowledge of FDA regulatory requirements, including cGxP, GLP, GMP, Sarbanes-Oxley (SOX), 21 CFR 210/211, 21 CFR 58...

Tags for this Online Resume: Services, Data Migration, Legacy, Quality Assurance, Assessments, Audit, Management, Quality Management, Pharmaceutical, Quality, validation, CSV, business analyst

Dietician or Nutritionist - 10 Years of Experience - Near 90272

Summary With a Background of clinical medicine, molecular biology & Naturopathy, Evaluation of natural ingredients with scientific knowledge for safety & clinical based efficacy has been my core interest. Formulation development and manufacturing management of nutraceuticals and cosmaceuticals with cGMP HACCP application/compliance has been my major professional engagement. - Experience & Expertise in cGMP manufacturing man...

Tags for this Online Resume: Herbal medicine, Research and Development, Manufacturing, Microsoft Internet Explorer, formulation development, Nutraceuticals, Cosmaceuticals, Herbal extraction, Molecular Biology, Pharmaceutical Industry

Engineer - 20 Years of Experience

SUMMARY: Hands-on, Multidisciplinary Design Engineer with Project Management and NPI/NPD experience. Electrical, Mechanical, Electromechanical, Controls, Process, and Lean Manufacturing Systems Design, Development, Commissioning and Optimization. * Purpose Built Machinery Design, Development, and Automation for Manufacturing, Assembly, Packaging and Test. Design Specification to Installation and Commissioning, IQ/OQ/PQ (Pro...

Tags for this Online Resume: Electronics, Control Systems, Manufacturing, NEC, Power Distribution, Reliability, Troubleshooting, UL, IEC 60601, Systems Design

Manager - 20 Years of Experience - Near 53725

Resourceful professional with wealth of experience in branch and store operations management, including inventory/distribution control, purchasing, accounts receivable (AR), and sales/service. Strong background in start-up and growth of retail operations, supervising and training customer service representatives and delivery field technicians. Proven ability to guide range of healthcare administrative operations, such as Me...

Tags for this Online Resume: Southern Wisconsin, Flexible, Therapy, Billing, Budgeting, Health Care Industry, Insurance, Inventory, Inventory Control, Logistics, store manager, management, manager

Associate Director Medical Affairs- 11 Years of Experience - Near 76001

My objective is to advance in my career by accepting more challenging and strategic roles within a pharmaceutical company. I have 11 years of experience in ophthalmology, ranging from cornea, refractive lenses, cataract lenses, glaucoma, and retina, and would like to stay in this therapeutic area. I have a wide range of experience in a drug cycle, from basic bench science, testing in animal models, Phase I-III clinical st...

Tags for this Online Resume: Integrated Development Environments, Protocol, Medical, Medical Affairs, Publications, Science, Information Requests, Ophthalmology, Research, Cancer, oncology

Quality Manager

SUMMARY OF QUALIFICATIONS 21 years hands on experience in the Medical Device industry dealing with ISO, MDD & FDA compliance. 11 years regulatory affairs experience.

Tags for this Online Resume: Assessments, Inventory, Inventory Control, ISO, ISO 9001, Management, Product Design, Quality, Quality Assurance, Quality Management

Software Engineer

Quality orientated Biochemist and Software Engineer who resolved CAPA, developed medical instrument software requirements and assays, and supervised and trained colleagues. Certified Scrum Master. Wrote and performed verification/validation black box/white box software testing with consideration for User Design and FDA regulations. Solved hardware and software issues. Built and maintained effective working relationships wit...

Tags for this Online Resume: Chemistry, Protocol, Regression Testing, Test, Test Cases, Diagnostics, Design Documents, Microsoft, Software, Unix, SCRUM Master, Agile software development, FDA regulatory, UX design