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Online Resumes with "FDA requirements"



Featured Profile

Business Analyst - 15 Years of Experience - Near 84020

Overall Leadership responsibilities - The Global Product Controllership & Engineering Analytics Manager position will coordinate a cross-functional engineering, supply chain, quality and marketing implementation teams for all activities related to Product Controllership and the creation of a global analytics program to increase product reliability and customer satisfaction

Ideal Companies: Intermountain Medical Center, Texas Memorial Hospital, UNC, St. Mary's Hospital, Scripts Hospital

Tags for this Online Resume: Manager, Technology, Operational, Leadership, Healthcare, Siebel

Featured Profile

Senior Process Validation Lead

Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.

Clinical Quality Assurance - 20 Years of Experience - Near 34474

I am looking for a small company that wants to bring their medical device projects and designs through the FDA requirements up to and including sales and Post Market Surveillance. Start ups I believe, are the best projects to bring to market. Each one has a purpose, a validated effort, and an outcome for the employee to learn many activities and wear many hats.

Tags for this Online Resume: Tampa Bay, Jacksonville, quality Manager, Medical devices, FDA expertise, ISO expertise, Part 11 compliance, R

Project Manager - 20 Years of Experience - Near 30655

HIGHLIGHTS OF QUALIFICATIONS * Providing Key Project Management (PMP) as well as hands on experience in the Acquisitions and Mergers of business technology and business practices into new business platforms. This would be the integrating old business legacy systems with new technology or integration into new owner systems and software. Mergers with Airline, Banking and Automotive companies. * Senior management consultant wi...

Tags for this Online Resume: Security, Cellular, Software, Software Development, Strategic Initiatives, ACD, Vignette, Adobe, Automatic Call Distribution, e-Commerce, it jobs, agile, software, sql, Senior Program / Project Manager, M&A Consultant

Mechanical Engineer - 20 Years of Experience - Near 25545

Summary I am seeking employment in a position that will make use of my diversified background in mechanical engineering. As my attached resume shows I have been able to adapt my background too many different industries. I have been directly responsible for complete project development and management including the initial engineering sales effort through project development, build, installation and equipment validation. I ha...

Tags for this Online Resume: Instrumentation, Protocol, Team Lead, Manufacturing, Engineering, Consulting, IBM, Proposal Development, Automation, Documentation

Clinical Regional Monitoring - 20 Years of Experience - Near 18929

Seeking an opportunity with a Pharmaceutical, Biotechnology company or CRO as a Senior Lead Clinical Research Associate, Lead CRA, CRA Manager/Trainer (Mentor) and/or CRO Oversight Monitor to employ my 27 years of clinical research monitoring, management skills and CRA mentoring as well as19 years of Respiratory/Pulmonary and Cardiopulmonary critical care clinical medicine. Clinical Research Experience: Projects/Therapeutic...

Tags for this Online Resume: Pharmaceutical, Clinical Research, Research, Rheumatology, Biomedical Industry, Pharmaceutical Industry, Cardiology, Critical Care - Neurology, Critical Care - Respiratory, Neurology, oncology, clinical, phase, gcp, protocol, trial, ich

Quality Specialist – two years of experience – Qualification of raw materials - Quality Assurance – Compliance – Change controls- FDA requirements – SOP’s – cGMP-familiar with CAPA

In my two years of experience at Johnson & Johnson, I have gained vast knowledge about different areas : Quality assurance,Complaince, Procurement and Analytical but my goal is to excel in the field of Compliance/Quality Assurance with high level of persistence

Tags for this Online Resume: Compliance, Quality Assurance, Change controls, Leadership, SOP, Computer

Correspondence Clerk - 16 Years of Experience - Near 60085

PROFILE: Motivated, results-oriented Professional with extensive clinical and regulatory knowledge (Good Clinical Practices, Food and Drug Administration, The International Conference on Harmonization and other regulatory requirements), has 16 years experience in clinical support activities with a broad array of clinical database software programs. Possesses exceptional interpersonal skills to develop and foster working rel...

Tags for this Online Resume: Documentation, Filing, Database, Documentum, Documentum (Wkflow Sw), Support, Clinical Management, Management, Quality, Audit, Clinical Documentation

Quality Engineer - 19 Years of Experience - Near 92555

Professional Summary: Goal-driven Senior Production & Quality Manager with broad experience in fast-paced, high-tech environments requiring expertise in production scheduling, quality management, Project Management, training, cost control and Continuous Improvement Programs. Thoroughly familiar with a broad range of manufacturing protocols, including SMT, KANBAN, CONWIP, QRM, JIT, SPC, TQM, 5S, DFM, DMAIC, Kaizen, QFD, SMED...

Tags for this Online Resume: Inventory, SPC, Process Improvement, Product Launch, 5S, Audit, Clubs, Corrective Actions, Integrate, Inventory Control

Radiologic Technologist - 18 Years of Experience - Near 60525

Qualifications: ARRT Registered, IEMA certified, Advanced licensed in Mammography Twenty six years experience in Mammography Experience in State and FDA requirements and recommendations Supervisor and training of Mammography technologist

Tags for this Online Resume: ARRT, Special Procedures, Training, Mammography Technologist, Imaging, Medical, Quality, Quality Assurance, Mammography, Health Care Industry

Featured Profile

SENIOR PERSONAL CARE PRODUCTS CHEMIST WITH 15 YEARS OF EXPERIENCE IN FORMULATION, TESTING, AND REGULATORY STANDARDS

Applying my Education and Experience in Every Possible Way to achieve the Maximum Profitability and lowest Cost Possible to the Employer

Ideal Companies: Johnson and Johnson, Proctor and Gamble, Unilever, Colgate - Palmolive

Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), OTC, Quality, Chemist, Formula, Personal Care, Cosmetics, Household, QC, R & D, FDA, Consult

Featured Profile

Analytical Chemist

● Utilizes broad technical knowledge and troubleshooting skills to perform testing of a various biological matrices ● Utilizes Labnotes, Watson for transferring the samples and data ● Experiences in current Good Manufacturing Practice (cGMP), current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), requirements and Health Author...

Ideal Companies: Pharmaceutical

Tags for this Online Resume: Manufacturing, High Performance Liquid Chromatography (HPLC), Teamwork, Troubleshooting, Research, Instrumentation, Chemistry, HYGIENE, Millenium (Sw-Fin/Admin), Millennium