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Online Resumes with "FDA "
Lead Clinical Research Coordinator - 4+ Years of Experience - Near 48304
Tags for this Online Resume: SPSS, CCRP, IRB documents, Multicenter Clinical Trials, SAE reporting, Data management, internal monitoring, GCP and FDA regulations
Medical & Clinical Laboratory Technologist
Professional Summary Shows consideration for individual patients and their needs. Observes all safety and infection control protocols. Enthusiastic and capable of working independently as well as cooperatively. Remains very well organized and maintains thorough and accurate records. Consistently demonstrates poise and control when performing duties under pressure and handling stressful situations. Persistent, organized and ...
Tags for this Online Resume: Electrophoresis, Cellular, ELISA, Immunology, Microbiology, Clinical Research, COLI, Research
Clinical Research - 20 Years of Experience - Near 60601
-Participate in development of new intramural clinical research studies, both for solid tumors and hematology/oncology, reviewed all new protocols, supervised designing case report forms for the new protocols for the solid tumors and hematology/oncology. -Work with the multiple investigators on developing and implementing new intramural oncology protocols and supervised accomplishments with all protocols' requirements. ...
Clinical Research - 20 Years of Experience - Near 55442
Tags for this Online Resume: clincal, research, monitoring, director, fda, writing, protocol development
Clinical Regulatory Affairs - 9 Years of Experience - Near 07062
To gain a position wherein my training expertise, organizational and computer skills will be utilized effectively as an asset to overall organization.
Tags for this Online Resume: Documentation, Pharmaceutical experience, software support , FDA compliance , pre-clinical, Documentum, regulatory, LMS, Applications, Integrate, Lotus, Lotus Notes, Microsoft Frontpage, Microsoft Office, Microsoft Project, Electronic Publisher
Technical Writer
Thirteen years experience in multiple industries at all organizational levels coordinating technical documentation creation and editing while interfacing with Subject Matter Experts, on-site engineers and technicians, and business partners. Currently seeking challenging opportunity.
Tags for this Online Resume: MS Office, Adobe Framemaker, MS Project, Factory Automation, Laboratory, IQ, OQ, PQ, Validation, Commissioning
Director - 2 Years of Experience - Near 01440
Profile PROCESS MANAGEMENT SIX SIGMA INDUSTRIAL ENGINEERING MANAGEMENT WAREHOUSE MANAGEMENT DISTRIBUTION OPERATIONS MANAGEMENT Recognized as a hands on engineering, logistics and operational managing expert. Offering thirty years of accomplishments leading to increased profitability and superlative service delivery. Experienced in multi-unit management. * Proactive and results driven. Operational leadership with vision for ...
Tags for this Online Resume: Planning, Forecasting, Distribution, Policies and Procedures, Security, Housekeeping, Inventory, Management
Quality Coordinator - 14 Years of Experience
An accomplished multi-lingual medical program administrator/manager/trainer and auditor whose specialty in quality control, management analysis, risk and fiscal review of health care services/programs and departments, coupled with effective communication and case management expertise, thorough knowledge of QA practices, awareness of local, State and Federal government trends for quality controls and public safety of infecti...
Tags for this Online Resume: Management, Medicare, Coding, Fraud, Home Health, Risk Management, Services, Audit
FDA Regulatory Inspector
Principal Engineer
SUMMARY OF QUALIFICATIONS * Principal engineer, R&D and general management executive and scientific professional with B.S. M.S., Ph.D. and postdoctorate in science and engineering disciplines. * Successfully developed several prototypes and launched multiple FDA/CE regulated platforms, devices and Class I-II-III products and plastic consumables for medical, diagnostics, biotech and pharmaceutical applications from concept t...
Tags for this Online Resume: Orange County, CA, Medical Device, Research and Development, Principal Engineer, Manager and Director, FDA and CE regulated, Ph.D., Biotech
Microbiologist - 7 Years of Experience
PROFILE: Individual with a proven quality and compliance judgment along with strong influential skills who possesses leadership and general management ability, plus a track record of developing and enhancing quality system processes. Ability to develop, plan and execute long-term strategies to business needs while executing short term requirements. Proven record to develop, manage, execute and continuously build quality sys...
Tags for this Online Resume: Protocol, Appraisals, Compensation, Documentation, Quality, Quality Assurance, Quality Control, Test
Clinical Quality Assurance - 17 Years of Experience - Near 27713
QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...
Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance
