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Online Resumes with "FDA "



Featured Profile

Director of Human Resources - 20 Years of Experience - Near 95135

I would like to apply my broad and indepth Human Resources Leadership skills and experiences to supporting a company as it looks to enhance its Human Resources practices.

Ideal Companies: Stryker, Becton Dickenson, Kaiser

Tags for this Online Resume: Acquisitions, Mergers, Mergers and Acquisitions, Leadership, Leadership Development, Assessments, Human Resources, HR, Management, Benefits, Employee Relations, Coaching, Consulting, Performance Management, Strategy, Change Leadership, Recruitment

Compliance Manager - 20 Years of Experience - Near 30641

PROFILE Career-driven and results-oriented information-technology professional with a solid portfolio of managing information-technology projects as well as resolving complex technical issues. More than 36 years of progressively responsible experience and measurable accomplishments. Consistently recognized as being able to accelerate, perform, and enhance service. Strategic planner and creative-problem solver, Lead complex ...

Tags for this Online Resume: Compliance, Infrastructure, Quality, SDLC, Assessments, Audit, CFR Part 11, Geographic Information System, HP, Manufacturing, Risk Management, Project Management, SOX

Research Nurse - 15 Years of Experience - Near 90603

To seek employments in the Pharmaceutical Industry to utilize my educational experience and expertise as a health care educator and clinical trials nurse educator, and act as a key team member to support and promote the development of a drug or device with a sucessful outcome of FDA approval.

Tags for this Online Resume: Nursing, Research, Research/Education, Oncology, Gastrointestinal, Public Health, Science, Clinical Research, ICU, Cancer, Clinical Trials Educator, Clinical Trials Nurse Liaison, Clinical Trials Nurse Educator, Trials Nurse Educator, Study Nurse Educator, Nurse Educator, MSN Ed

Project Manager - 18 Years of Experience - Near 32312

producer Directed the Open Text professional services group to effectively install, customize, and implement SAP Archiving and Document/Data Access solutions. Met or exceeded group's revenue and margin targets and customer service expectations. Won major competitive accounts through pre-sales activities. Managed $1M budget and 10 consultant direct reports along with subcontracted SAP and Open Text professionals. * Teamed wi...

Tags for this Online Resume: Management, SAP, Imaging, Project Management, Consulting, Legacy, Risk Management, Audit, COBIT, Documentation

Scientist

SKILLS SUMMARY * Authored technical reports, research manuscripts, SOPs, IACUC and IRB review of protocols. * Knowledge of GLP, ICH, FDA and NIH regulations, CITI training. * Reviewing, Editing, QC, and Finalization of documents and research grants. * Extensive knowledge of MS-Word, Excel, PowerPoint and Microsoft Access. * Proficiency in GraphPad Prism, FlowJo, Sequencher and Geneious. * In-depth scientific knowledge of Im...

Tags for this Online Resume: immunology, virology, clinical research, regulatory

Biomedical Engineer - 2 Years of Experience - Near 94105

SUMMARY A highly skilled Biomedical engineer familiar with every aspect of medical devices from concept to commercialization. Qualifications include design history file management, SOLIDWORKS associate certified (in progress), 3D printing and prototyping, six-sigma methodology, FMEAs, manufacturing process, FDA submission.

Tags for this Online Resume: Biomedical Industry, Bluetooth, C++ Programming Language, Documentation, Engineering, Management, Manufacturing, Biomedical engineer, Medical devices, Solidworks, Six sigma, FMEAs

Business Analyst - 2 Years of Experience - Near 32301

Biotechnology and a Business Professional seeking an opportunity in the field of Regulatory Affairs

Tags for this Online Resume: FDA, ICH, Auditing, Complaint files, Microsoft Office, Microsoft Visio, HIPPA Regulations and Compliance, Drug Regulatory Affairs, Business and Requirements Gathering and Analysis, Process Mapping and Improvement, Microsoft Project Professional

Clinical Research - 12 Years of Experience - Near 78254

SUMMARY OF QUALIFICATIONS * Managed Phase I -IV and observational Clinical Research Trials for HIV/AIDS, HIV Vaccine trials, HIV and Hepatitis, Infectious Diseases, Hyperlipidemia, Diabetes, Renal CKD, Secondary Hyperparathyroidism, Vitamin D Deficiency, Diabetic Nephropathy, Allergies, Asthma, and Immunology, Hepatic therapeutical area, from HBV, HCV, Fatty Liver, Cirrhosis in the Liver, medical devices. * As an inhouse mo...

Tags for this Online Resume: PEDIATRIC, Pharmaceutical, Surgical, C Programming Language, Data Entry, Hepatitis, Hepatitis C, Research, Therapy, Cardiovascular

Mechanical Engineer - 15 Years of Experience

Career Summary 10+ years' experience in Project Management, R&D, Medical Devices, Film, Paper & Plastic Converting, RFID, Semiconductor, Automotive & Textile Industries Areas of Expertise Working under pharmaceutical OSHA / FDA / ISO regulated requirements

Tags for this Online Resume: Documentation, ISO, Manufacturing, OSHA, Pharmaceutical, RFID, Security, Medical, Medical Devices, TQM (Total Quality Management)

Supply Chain Manager - 17 Years of Experience - Near 48334

Summary: Qualifications: * ISO and QS-9000/9001/TS1649 certification/ISO Auditor. * Lean Manufacturing, Production, Inventory Control and Transportation. * Six - Sigma/5S Lean Manufacturing/Production/Subassembly. * FEMA Process Solutions./Kiazen/Toyota Systems. * KAN BAN - MIN MAX - Cycle Count - Physical Inventory - FIFO processes. * Process integration and Material Handling solutions skill set. * WMS bar coded/voice deli...

Tags for this Online Resume: Inventory, Inventory Control, Logistics, 3PL, Audit, Management, Manufacturing, Purchasing, Training, Transportation

Production Supervisor - 20 Years of Experience - Near 50501

SUMMARY OF QUALIFICATIONS QUALITY CONTROL/QUALITY ASSURANCE MANAGER with extensive experience in analyzing and solving product and process related problems. Proven ability to use innovative approaches to proactively develop efficient, cost saving solutions to problems in a variety of work environments. Easily establish rapport with co-workers and department managers to accomplish goals. Successfully achieved and exceeded co...

Tags for this Online Resume: Quality Assurance, Quality Control, Process Control, Scheduling, Test, Training, Troubleshooting, Six Sigma Black Belt

Life Scientist - 13 Years of Experience - Near 80305

Tags for this Online Resume: Boulder, R, Pharmacokinetic, Programming, CDISC, Pharmaceutical Industry, FDA, Data Science, Data Analysis, Data standards, Technical editing, Research