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Online Resumes with "FDA regulation"
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
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
Clinical Research
Experienced Clinical Research Associate seeking a challenging and rewarding Clinical Research Associate (CRA) position that will utilize my clinical site monitoring and general management skills and experience to coordinate, monitor and manage all aspects of clinical trials in accordance with the ICH-GCP guidelines, FDA regulations, standard operating procedures and study protocol.
Clinical Research - 6 Years of Experience - Near 75287
PROFESSIONAL SUMMARY: A CRA with strong eye for detail and exceptional ability to interpret and follow instructions Possesses the ability to collect accurate data in line with client specifications excellent analytical and organizational skills knowledgeable in FDA regulations, GCP/ICH guidelines, seeking to join an organization that makes research subjects' safety its first priority. CORE QUALIFICATIONS: * Over 5 years exp...
Tags for this Online Resume: Management, Clinical Research, Data Management, Protocol, Research, Assessments, Forth Programing Language, Good Clinical Practices, Monitoring, Training
Biological Technician - 15 Years of Experience - Near 94547
Obtain a challenging position to utilize 15 years of experience in the biotechnology industry. Help company achieve optimum operational excellence while producing successful results in lean manufacturing. Increase process efficiency with a focus on safety. Skilled professional to achieve success and increase productivity in a quality controlled safe cGMP environment
Ideal Companies: BioMarin
Tags for this Online Resume: Biotech, cGMP, FDA, AsepticTechnique , ISO, SAP, Quality Control, manufacturing, Compliance, Monitoring
Clinical Research
PROFESSIONAL SUMMARY: Licensed Pharmacist from India with Masters in Pharmacology. Over 7+ years of experience in the Pharmaceutical industry with focus in Pre-clinical and clinical trials and a strong understanding of cGMP, GCP, FDA regulation and ICH guidelines. Have an Extensive knowledge as a Quality Assurance officer and outstanding interpersonal skills with a track record of establishing positive relationships with cu...
Tags for this Online Resume: Clinical Research, Email, Management, Project Management, Project Manager, Protocol, Research, Canvas
Study Coordinator
Summary Study Coordinator with 6 years' experience specializing in technical support of animal studies requiring GLP compliant interpretations, analysis, documentation, and reporting of results per FDA regulations beginning with protocol development support and creation of shell reports resulting in a Final product ready for FDA Regulatory Filings. Areas of Expertise / Core Competencies * Highly dependable, focused and dete...
Tags for this Online Resume: Documentation, Good Laboratory Practices, Protocol, Analytical Skills, Biomedical Industry, Quality, Quality Assurance, Coordinator, Medical Devices, Regulatory
Quality Engineer - 19 Years of Experience - Near 77459
SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485
Clinical In-house Monitoring - 6 Years of Experience - Near 07621
SUMMARY OF QUALIFICATIONS Pharmaceutical professional with 5+ years of clinical research experience in management and monitoring. Seeking new and exciting opportunities in new therapeutic areas to expand my expertise. Known for building strong relationships with clients and partnering with management teams to ensure quality services, compliance and efficiency. Manage Clinical Research, third party vendors, and clinical inst...
Tags for this Online Resume: Fraud, ICD-9, Insurance, Medical, Query, Management, Good Clinical Practices, ICH, Documentation, Clinical Research
Clinical Research - 2 Years of Experience - Near 77449
HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety ...
Tags for this Online Resume: Direct Patient Care, DRESSING CHANGES, Medical, Patient Care, Suctioning, Surgical, Wound Care, Acquired Immune Deficiency Syndrome (AIDS), HIV, Monitoring
Pharmacist - 7 Years of Experience - Near 27516
Professional Summary: A healthcare clinician with a PhD in Pharmacy and a specialty in pulmonary medicine and a master's degree in Organizational Management/Project Management seeks an opportunity to transition into clinical research in order to apply business skills with clinical skills, and FDA regulations preferably overseeing clinical research projects. My goal is to direct or coordinate clinical research projects to en...
Tags for this Online Resume: Benefits, Biomedical Industry, Insurance, Pharmacology, Research, Drug Utilization, Inventory, Medical, Medical Records, Therapy
Electromechanical Equipment Assembler - 1 Years of Experience
SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.
Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control
