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Online Resumes with "FDA"
VP Research and Development - 16 years experience - RTP, NC
SUMMARY Biotechnology professional with experience spanning drug discovery, development and manufacturing (small molecule - and biologic- based drugs), analytical R&D biological and pharmaceutical operations, and commercialization. Experience in contract research organization (CRO) partnering. Extensive involvement in medical device (FDA 510K), biomarker based science for drug discovery, clinical development, process develo...
Tags for this Online Resume: Immunology, Cellular, Management, ADA, Budgeting, ELISA, Infectious Diseases, Manufacturing, Ada Programming Language, Bacterial Transformation
Clinical Research - 7 Years of Experience - Near 37208
Summary of Qualifications Detail-oriented, enthusiastic, and highly motivated Research Professional with 19+ years of successful experience. Diverse background encompasses research, laboratory analysis, reporting, and project/study planning and execution experience. Skilled at ensuring compliance with Standard Operating Procedures (SOP), Good Clinical Practices (GCP), and applicable policies and regulations. In-depth knowle...
Tags for this Online Resume: Instrumentation, Research, Quality, Quality Assurance, Quality Control, ISO, Toxicology, Leadership, Automation, Chemistry
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
Director of Quality
Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12 of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, project-management and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, supplier management and all aspects...
Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management
Clinical Research
To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. Achievement: Co-Author on Two Research Article Publications
Tags for this Online Resume: Clinical Research, Documentation, Research, Management, Monitoring, Outsourcing, Policies and Procedures, Protocol, Training, Accounting
Statistical Programmer - 5 years Experience - US
Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...
Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test
Clinical Regional Monitoring
Accomplishments: * Compliance- Maintained compliance with regulatory standards. Ensuring site staff was trained and followed all guidelines set forth by the FDA. * Implementation-Implemented a new tracking system that resulted in improved query resolution. * Documentation-Ensured study sites followed ALCOA to ensure accuracy of through precise documentation. * Patient Safety-Ensured quality control through following ICH/GCP...
Tags for this Online Resume: Audit, Compliance, Data Quality, Documentation, Forth Programing Language, Good Clinical Practices, ICH, Management, Monitoring, Protocol
Biomedical Engineer - 16 Years of Experience - Near 01757
Professional Summary 20+ years' success leading engineering innovation for high-growth organizations * Over 20+ years of extensive experience in Electrical & Electronic Engineering professional and Technical lead for many engineering projects including "Flex-Cardio product performance test in the production line the CO2 transducer Exchange and repair Managed daily product build in production floor - Manage Projects processi...
Tags for this Online Resume: Low Voltage, Debugging, MOSFET, Program Manager, Project Management, Project Manager, Test, Total (Db For Lg Comptrs), Total Systems, Medical
Microbiologist
A Validation Engineer with proven success working with major pharmaceutical companies and diversified experience across all aspects of the industry: Quality control manufacturing regulatory compliance and multiple departmental operations. Consistently demonstrating a high level of experience in all aspects of the development execution and close out of commissioning/qualification programs using process design documentation p...
Tags for this Online Resume: Manufacturing, Assessments, Automation, Utilities, Microbiology, Protocol, Collection, Documentation, High Performance Liquid Chromatography (HPLC), Marketing Management
Clinical Research
PROFILE Decisive, action-oriented and results-focused professional offering more than 30 years of experience in the medical field with 23 years focused in clinical research. Thorough knowledge of Medicine. Ability to deal with the public in a professional, concerned manner and ability to convey a sense of confidence and trust to patients and work well with other health professionals. Knowledgeable of FDA, ICH and GCP guidel...
Tags for this Online Resume: ICH, EKG, Research, C Programming Language, Catalogs, Clinical Research, Hematology, Hepatitis, Hepatitis C, Scheduling
Administrative Assistant
Zimmerman Supervisor: Gerri Comasta, Office Manager, Tel: (240) 453-0220 Salary $25.00 per hour, Private Sector * Expedited actions in a timely manner from the Office of the Director and HR Specialists * Reassign, realign and delete personnel records and actions in NFC (National Finance Center) and PowerTerm software application database * Replied to incoming emails from employees regarding pay issues and problems. * Met wi...
Ideal Companies: Staffing Agencies, Individual Companies, Retail Businesses
Tags for this Online Resume: Services, Benefits, Bonds, Deductions, Deposits, Email, Management, Documentation, HR, Human Resources
Quality Manager
CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...
Tags for this Online Resume: Process Control, Management, SPC, ISO, Policies and Procedures, Project Management, Project Manager, Quality, Quality Assurance, Quality Management
