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Online Resumes with "fda"
Clinical Research
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: Oncology, Research, Clinical Research, Microsoft PowerPoint, Microsoft Word, Oracle, Recruiting, Staffing & Recruitment, Computer Aided Software Engineering, Good Clinical Practices
Chemical Plant System Operator - 20 Years of Experience - Near 08753
SUMMARY: Over Thirty years' experience in positions of increasing responsibility within the Pharmaceutical and Consumer Divisions of Johnson & Johnson, FMC and Cardinal Healthcare, have provided the opportunity to develop a strong knowledge of FDA, GLP Guidelines, Practices and GMP's as set forward in the Quality System Regulations (Section 820 of The Act). Skilled in both Production Floor, Pilot Plant and Laboratory Enviro...
Tags for this Online Resume: Research, Consumer Products, Medical, Medical Devices, Notebook Computer, Product Development, Wound Care, Quality, Amaps (Mrp/Cim Sw), manufacturing, production
SR Director has
Accomplishments included: * Program Manager responsible for day to day leadership, management, and 1.3 million dollar annual budget to make sure TTI meets the needs of the FDA project manager and the business customer for Electronic Submission Portal for the Center for Drug Evaluation and Research for Operations and Maintenance and Development Enhancements. * Responsible for Business Development Management and writing gover...
Tags for this Online Resume: Accounting, Agile Methodologies, Agile methodology, Applications, Appraisals, Assessments, Audit, Budgeting, Business Development, CIO, agile, it jobs, software
Quality Manager
MAJOR ACCOMPLISHMENTS: * Instrumental in increasing approximately $3 Million in revenues in the first year by developing and implementing a novel UV curing process to terminate stimulating hydro-gel used in the manufacture of neuro stimulating and sensing electrodes. * Saved approximately $2 Million in the first year by eliminating scrap, returned devices, customer complaints, legal suits and consulting fees by changing and...
Tags for this Online Resume: Documentation, Manufacturing, Quality, Quality Assurance, Quality Control, Complaints, Test, Audit, Fraud, Health Insurance
Clinical Regional Monitoring - 12 Years of Experience - Near 30339
Profile A conscientious Research Associate with 30 years of diverse experience in product development, quality assurance as well as technical service and clinical research. A persistent self-starter experienced in operating and training personnel in a variety of analytical instrumentation and procedures. Successful in finding innovative solutions to a wide range of problems in a team environment or alone. inVentive Health C...
Tags for this Online Resume: Clinical Research, Research, Training, Management, Support, Technical Support, FRACTURES, Instrumentation
Director of Quality - 20 Years of Experience - Near 91709
SUMMARY OF QUALIFICATIONS * Over twenty years of experience managing regulatory affairs (RA)/quality assurance (QA), quality control (QC)/research & development (R&D) departments in pharmaceutical, medical device and dietary supplement manufacturing industries. Implemented Quality Management Systems meeting domestic and international regulatory requirements and ISO registration. Reviewed pre-clinical, clinical and pharmacok...
Ideal Companies: Pharmaceutical, Medical Device, Biomedical
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Microbiological Testing, Test, ISO, Pharmaceutical, ADA
Medical or Health Services Manager - 18 Years of Experience - Near 91321
PROFESSIONAL SUMMARY Licensed insurance professional with extensive experience in sales, prospecting and lead generation. Seeks a position offering new challenges and opportunities for career growth and advancement. Accomplished Compliance and Regulatory Affairs Specialist and Insurance Consultant who proudly maintains a highly productive, efficient and quality-driven environment in the ever changing health care regulatory ...
Ideal Companies: DME Supplier
Tags for this Online Resume: Documentation, Policies and Procedures, Services, Sales, Advertising, Compliance, Management, Quality, Regulatory Affairs, Securities
Clinical Quality Assurance - 20 Years of Experience - Near 84121
SUMMARY Quality professional with a MBA and solid technical experience in a laboratory environment and in a highly regulated manufacturing environment. Expertise includes leading teams, quality support through planning and production and Material Review Board (MRB) activities, validation, raw materials and finished product testing. Solid knowledge of regulatory requirements including cGMP/cGLP/cGCP/OSHA/CDC/CAP/EHS/FDA/DEA....
Tags for this Online Resume: Inventory, Inventory Control, Oracle, Pharmaceutical, Protocol, Quality, Quality Assurance, Quality Control, Scheduling, Structural Testing
Manager
PROFESSIONAL SUMMARY I am seeking an IT leadership position. I have excellent team building skills and strong technical skills. I have consulted for large organizations including Google, Visa, Robert Half International, San Jose Water, Oracle, Sun, Sega, San Jose State University as well as dozens of startups. I have been the project manager on numerous rollouts and technology migrations. I have the ability to explain techn...
Tags for this Online Resume: Wireless, Structured Query Language, Accounting, e-Commerce, Manufacturing, NOC, Retail, SAP, Software, Software Development
Biochemist
Professional Summary: * Superior problem solving skills, QC/QA validation, GLP protocol expert, FDA facility and 510k * qPCR designs, Elisa, SOP validation, Automated System (Tecan), Statistical analysis * HPLC, Flow Cytometry, Chromotography, Analytical Chemistry, Real Time PCR
Tags for this Online Resume: Research, Product Launch, Protocol, Quality, Quality Assurance, Quality Control, Filing, Packaging, Problem Solving, Problem Solving Skills
Manager - 20 Years of Experience - Near 00605
CAREER SUMMARY Accomplished professional recognized as a focused leader and strategic problem-solver with a strong record of achievement in a variety of environments including Finance, Human Resources, Inventory Control, Sales, Customer Service, Planning and Purchasing. Over fifteen years of private accounting/finance in manufacturing, retail, wholesale, and governs entities with progressive growth and advancement in superv...
Tags for this Online Resume: management, manager, Complaints, Customer Service, Sales, Audit, Automation, Data Entry, Integrate, Internal audit
Clinical Research - 20 Years of Experience - Near 32828
My career objective is to become a part of your Organization and to apply my experience and knowledge during the conduct of clinical trials, with emphasis on safety, efficacy in accordance to ICH-GCP, FDA and study protocol guidelines. Further, I will always strive to accomplish efficiency and savings for clients, by developing effective monitoring tools
Tags for this Online Resume: Microsoft-Office, ICH-GCP, FDA-guidelines, CTMS, EDC, RAVE, Monitoring, Clinical trials, Cardiovascular, Management, Auditing
