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Online Resumes with "Method Validation "
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
Machinist - 8 Years of Experience - Near 78572
+ Responsible for test method Development + Responsible for Test Method Validations + Verification Protocols, Runs and Lab tests
Tags for this Online Resume: Industrial Engineering, Inventory, Lean Manufacturing, Logistics, Management, Manufacturing, MCAD Solidworks, Metrics, Microsoft, Microsoft Excel
Microbiologist - 6 Years of Experience
Qualifications of equipment's. * Analyst qualifications. * On the Job training. * Testing method validation. MAJOR AUDITS FACED: USFDA, TGA, MHRA, ANVISA (Brazil), UKRAINE, GSK, NHL, W.H.O, DRUG CONTROLLER AUDIT. VALIDATION EXPOSURE: * Media fill validation * Antibiotic bio assay * Excel sheet validation for calculations. * Sterility method validation * Bioburden method validation * Microbial Enumeration Test * Bacterial En...
Tags for this Online Resume: Microbiology, Quality, Quality Assurance, Quality Control, Distribution, Test, Training, Audit, Communication Skills, English Language
Quality Assurance Specialist - 20 Years of Experience - Near 84014
SUMMARY Innovative, energetic Quality Assurance Engineer with experience in Project Management, Development and Requirements Analysis, which gives me a unique understanding of what each department has to accomplish and the pressures they have to deal with. I have also worked with teams from India, South America, Ireland and China. This knowledge has made it much easier to communicate intelligently and more productively with...
Tags for this Online Resume: Applications, C# Programming Language, Test, Test Plans, Test Scripts, Selenium Framework, Defect Tracking, Servers, Team Foundation Server, Visual Studio, Automation, Permormace Testing, sql, agile, html
Biochemist - 13 Years of Experience - Near 19341
SUMMARY Highly intelligent Senior Scientist with extensive R&D experience in method development and method validation using wet chemistry and LC/MS/MS (AB Sciex 4000, 5000, 5500, 6500, Aglient 6410), GC/MS & ELISA instrument. Strong lab management and instrument trouble shooting skills
Tags for this Online Resume: ELISA, Research, Test, Protocol, Quality, Quality Assurance, Quality Control, Services, Chemistry, High Performance Liquid Chromatography (HPLC), pharmaceutical, clinical
Chemist - 15 Years of Experience - Near 92881
Experienced with trouble shooting issues in chromatography and other testing procedures resulting in effective and high quality test methods * Maintained daily, weekly, and quarterly checks of instrumentation such as stability chambers and HPLC systems as part of team responsibilities, reducing the need for a separate metrology group Scientist II (Laboratory Technical Services) 2011 Performed remediation activities for exis...
Tags for this Online Resume: Filing, Forth Programming Language, Quality Assurance, Regulatory Affairs, Test, High Performance Liquid Chromatography (HPLC), Instrumentation, Quality, Quality Control, Compliance, pharmaceutical, sop, change control, method validation, cleaning validation, hplc, fda, raw material, in-process testing, finished product, solid dose, research and development, method transfer, protocol, report
Laboratory Technician - 20 Years of Experience - Near 02745
ACCOMPLISHMENTS: Mechanical Design and Testing. Designed various machine parts for tensile testing application to facilitate the company' existing test method for footwear product such as foam, rubber, and fabrics. This test method is used to measure the energy characteristics of different material. Machine Design. Designed a machine to conduct R&D test evaluation on spineless golf shoes for various surfaces. Materials anal...
Tags for this Online Resume: ISO, ISO 9000, Science, Purchasing, Transportation, Management, Documentation, Manufacturing, Quality Assurance, Statistical Analysis
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Biomedical Engineer - 17 Years of Experience - Near 92604
Summary R&D Team Leader and engineering professional with extensive experience in the medical device industry, and strong academic background. Expertise in product development, risk assessment, CAD, Solidworks, test method validation, design control, biomaterials, tissue biomechanics, clinical studies, plastics, and finite element modeling. Key strengths include management, problem solving, innovation. Hands-on troubleshoot...
Tags for this Online Resume: MCAD Solidworks, Risk Assessment, Manufacturing, E3, ISO, Research and Development, Surgery, Surgical, Development Activities, PEDIATRIC, mechanical engineering
Tester - 4 Years of Experience - Near 85032
PROFESSIONAL SUMMARY * A result oriented individual with over Four years of diversified experience in Quality Assurance and System/Application testing in Healthcare and Web based applications. * Expertise in testing various applications developed in Java, .Net. * Performed planning and created Test Plans, Test Cases and Test Scenarios to meet product's business requirements. * Experience in developing testing documents - Te...
Tags for this Online Resume: HP, Test, Test Plan, Active Server Pages, Defect Tracking, Quality, Quality Center, Planning, Test Plans, Agile
Microbiologist - 20 Years of Experience - Near 07753
Summary I am a Scientist with twenty nine years of professional experience in the pharmaceutical, medical device, clinical and biotech industries. I have written SOPs, CAPA, audit reports, validation master plans, protocols, new product submissions and various other technical documents. I am very familiar with QSR, 21CFR211 and ISO standards: 13485, 14644 part 1 and part 2. I have used the five "whys" and fishbone methods f...
Tags for this Online Resume: Data Entry, Documentation, Root Cause Analysis, Technical Writing, Packaging, ISO, Pharmaceutical, Statistical Analysis, Audit, Management, pharmaceutical, sap
Chemist - 20 Years of Experience - Near 19020
Summary * Top-performing, self-confidant professional with over twenty five years of experience in analytical method development and method validation. Due diligence and auditing of third party analytical documents as per US guidelines. Extensive experience in HPLC, Gas Chromatography and dissolution methods developments. Hands-on experience in cGMP and cGLP procedures. Ability to work independently and manage team projects.
Tags for this Online Resume: Drafting, Quality, Quality Assurance, Quality Control, Research and Development, Documentation, Filing, Protocol, High Performance Liquid Chromatography (HPLC), Chemistry, pharmaceutical, ich, ICH, protocol, method development research and development
