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Online Resumes with "GLP "
Chemist - 13 Years of Experience - Near 84414
in large and small laboratory operations Factory Training from SCIEX Agilent Technologies Waters Corp Bruker Daltonics and TECAN Skilled in LC/MS/MS method development in a GLP environment Skilled in a variety of Liquid and Gas Chromatography Mass Spectrometry Techniques
Tags for this Online Resume: Budgeting, Research, SAN (Storage Area Network), Instrumentation, information technology, Field Service Engineer
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Health Technologist
SUMMARY Analytical Chemist with expertise in quality control, stability studies, research and development, and manufacturing. Exceptional ability to work independently and as a team member. Skills include: * Subject Matter Expert on NMR (Bruker Avance 400 MHz) Trained five QC analysts on methodology of NMR assays and revised SOP for NMR assay * Performed troubleshooting for instrument operations, test results, and project i...
Tags for this Online Resume: Pharmaceutical Industry, Quality, Quality Assurance, Quality Control, Test, High Performance Liquid Chromatography (HPLC), Spectrophotometer, Instrumentation, Manufacturing, Research
Life Scientist
Professional Summary Objective: A passionate, creative and result-oriented interdisciplinary scientist, committed to scientific excellence and innovation in Research & Discovery of Biologics and Biotherapeutics Accomplishments: * Accomplished author and reviewer of scientific contributions in peer-reviewed journals. * Presented scientific results within cross-disciplinary teams, meetings and conferences. * Trained/mentored ...
Tags for this Online Resume: New Jersey, Vendor Management, Interdisciplinary Scientist, Technical, Leadership, Collaborative team builder,, Life Science Manager, R&D, Biologics, Good Practices in Health and BioSafety, GLP, Database, Bioinformatics, Computer skills, Microsoft Office tools, Adobe, Scientific/Technical/Computational Skills, Accomplished author, Technical writer and reviewer, Genomics
Biologist - 20 Years of Experience - Near 07747
SUMMARY * A dedicated, hardworking and dependable scientist with 20 years of experience in in vivo pharmacology * Extensive experience in designing, executing, interpreting and presenting the results of preclinical studies in small and large animal models * Successfully developed, implemented and validated computer data acquisition systems and data management applications to reduce cost, increase efficiency and improve busi...
Tags for this Online Resume: Critical Care - Vascular, Oncology, VASCULAR, Telemetry, Cardiovascular, Management, Pharmacology, Data Management, Pulmonary, Applications, animal surgeries, immunology, computer technologies, ex vivo assay
Scientist - 6 Years of Experience - Near 20705
Self-driven and detail oriented research scientist with over ten years of experience in research and development I have more than 10 years of experience in the following fields * Chromatographic / spectroscopic method development, validation, and analysis (GC - MS, LC - MS, CE, Q-TOF-MS, GC-TOF-MS, MALDI, Electrophoresis, ) * New drug candidate identification from natural sources * Biomarker development * Handling large dat...
Tags for this Online Resume: Cancer, Proteinx, peptide, Mass Spectrophotometer, HPLC, UPLC, MALDI-TOF-MS, Method developmet, GC-MS, MS/MS, Method validation, Chemometric analysis, SIMCA, SPSS, Microsoft
Biochemist - 20 Years of Experience
SUMMARY Highly organized, self-motivated Senior Research Scientist with very solid and pertinent experience in drug metabolism and pharmacokinetics (DMPK) support. Extensive knowledge in pharmacokinetic principles and biochemical drug metabolism reactions. Strong scientific and instrumentation background in Pharmaceutical Industry and GLP Analytical work. Excellent skills in analytical method development, assay validation, ...
Tags for this Online Resume: Automation, Troubleshooting, Clinical Programs, High Performance Liquid Chromatography (HPLC), Research, DPS, Notebook Computer, Robotics, Training, Audit
Business Analyst - 17 Years of Experience - Near 11725
SUMMARY Business Analyst / Validation Lead / Specialist / IT/QA Compliance Specialist with Pharmaceutical, IT, Manufacturing and Software QA experience: An IT professional with extensive experience in QA/Compliance, Testing, SQA, PM, Validation and Documentation specialties include: * Business Analyst experience consists of specializing in writing business workflow processes and translating them into Business, Functional an...
Tags for this Online Resume: Compliance, Information Technology, Test, Quality, Training, Good Clinical Practices, HP, ISO, Good Laboratory Practices, Manufacturing
Chemist - 13 Years of Experience
SUMMARY OF QUALIFICATIONS: * Strong organizational and technical skills, highly efficient a quick learner. * 13+ Years of experience with Analytical Testing within GMP environment. * Understands and complies to ICH guidelines, cGMP, GLP, and FDA regulations. * Very enthusiastic and motivated in learning new instrumentation and methods. * Work effectively under high pressure environment and never compromise with ethics and q...
Tags for this Online Resume: Quality, Quality Assurance, High Performance Liquid Chromatography (HPLC), Documentation, Instrumentation, Software, Test, Troubleshooting, 5S, Documentum
Business Analyst - 7 Years of Experience - Near 08817
Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...
Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project
Clinical Research - 5 Years of Experience - Near 20833
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Toxicology, Mass Spectrometry, Assay Development, Method Validation, Analytical Chemistry, LCMS, Drug Discovery, Organic Synthesis, Therapeutic Monitoring, HPLC, UPLC, chromatography, qualitative analysis, quantitative analysis, pain management, antiretrovirals, solid phase extraction, proteomics, supervisory, leadership, communication skills, GMP, GLP, small molecules, technical documentation, diagnostics, Data Analysis, Bioassay, Clinical Trials, Biomarker, Translational, MS troubleshooting, SOP's, Research, Submissions, NMR, Subject Matter Expert, Biotechnology, Pharmacopoeial Analysis, high throughput, screening, TECAN, molecular targets, Exactive, Q-Exactive, LX, TX, Pharmaceutical, Analytical, Clinical, Orbitrap, tandem mass spectrometry, triple quadropole, UPLC Transcend, ESI, APCI, Sample Preparation, Protein Separation, PCR, Compliance, Methodology, therapeutic, MS Word, MS Excel, MS Office, Analysis software, Gaithersburg, MD, Rockville, MD, Silver Spring, MD, Washington, DC, Columbia, MD
Clinical Quality Assurance - 15 Years of Experience - Near 27513
Summary * More than eight years of Quality Assurance (QA) and regulatory experience abiding by GCLP, GLP, GMP, ISO/IEC 17043, GxP, and HIPAA. * Excellent problem solving, risk analysis and organization skills * Strategic thinker with strong interpersonal skills * Able to initiate and complete assigned tasks, work independently, and maintain team orientation skills * Professional, flexible and creative
Tags for this Online Resume: Standard Operating Procedures, Quality Management Plan, Quality Assurance, Internal, in-process, External, Vendor Audits, ISO, Word, Excel, Power Point, Study-Specific Plans, Good Laboratory Practices, Good Manufacturing Practices, Quality Assurance Training
