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Online Resumes with "test method validation"

Senior Scientist - M.S. Biologist, medical diagnostic industry, 20+ years experience. R&D, Manufacturing, Quality Assurance, Technical Support, and Quality Systems.

M.S. Biologist, molecular biology background, medical diagnostic industry. Experienced in R&D, Manufacturing, Quality Assurance, Technical Support, 21 CFR 820, audits, submissions and FDA communications. Proficient in technical reports, documentation, presentations, analytical instrumentation (HPLC, CE, UV-VIS), statistics (JMP, DOE, SPC, specifications), immunoassay development (ELISA, purification, conjugation), test meth...

Tags for this Online Resume: Medical Device, Quality, Auditing, molecular biology, manufacturing, regulatory, Quality/Regulatory, Biologics Manufacturing, MicroBiology/Environmental Monitorrig, Regulatory Affairs

Analytical Chemist-GMP Testing, Methods Validation/Transfer/Reports, Actavis, Mount Prospect, IL.

Sr. Analytical Chemist

Featured Profile

Process & Project Engineer

Process Engineer with five years experience in the medical device industry. Strong background in product and process development. Domestic and international experience in manufacturing environments. Innovative problem solver with the versatility to work in teams of all sizes. Trained in Lean and Six Sigma Process Excellence methodologies. Two years experience in Operations Management.

Ideal Companies: Siemens, Johnson & Johnson, Baxter, Amgen, Medtronic, General Electric, Covidien, Stryker

Tags for this Online Resume: development, validation, quality, qualification, Engineering, Manufacturing, Medical, Project Management, Project Manager, Supply Chain

Clinical Quality Assurance - 20 Years of Experience - Near 94403

QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.

Ideal Companies: small start-up company

Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)

Not Listed - 7 Years of Experience - Near 30046

Summary * Six Sigma project manager experienced working on process improvements on cross functional teams personnel * Recognized Rituximab density calculation error within LIMS Master Data and initiated appropriate CAPA remediation procedures which saved subsequent downstream lots from disposal * Analyzed, identified, and implemented cost savings opportunities for process improvement and operational excellence * Produced re...

Tags for this Online Resume: Process Improvement, Inventory, Management, Inventory management, Integrate, Operational Excellence, Process Improvements, Quality

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

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

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

Electrical Engineer - 11 Years of Experience - Near 10930

Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...

Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery

Chemical Plant System Operator - 15 Years of Experience - Near 60101

SUMMARY * Bachelor Degree in Science in Biology and has extensive years of laboratory experience. * Adherence to GMP, ISO Standards and OSHA procedures. * Performed PH, percent solids, conductivity, UV/Vis, Gel Electrophoresis, Carl fisher, fill weight as additional testing including simulation runs on the actual diagnostic instruments. * Knowledge / experience in Process Validation, Test Method Validation, Vendor Qualifica...

Tags for this Online Resume: lab tech , R, Safety, Tech Supp Lab Tech, word, Complaints, Distribution, Electrophoresis, Failure Analysis, OSHA, production, maintenance, manufacturing