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Online Resumes with "FDA"
Quality Professional
Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...
Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis
Scientist Manager - 19 Years of Experience - Near 02864
SUMMARY: Over fifteen years of Research & Development and manufacturing management experience in Biotechnology/In-vitro Diagnostics industry. Broad experience in Research and Development and Manufacturing. HANDS ON EXPERTISE: * Immunochemistry Assay Development for Lateral flow and Microfluidic, Wet Chemistry. * Molecular biology assay development, amplification techniques including PCR & RT-PCR. * Pharmacokinetics and Immu...
Tags for this Online Resume: Research, Research and Development, Diagnostics, Toxicology, Support, Technical Support, Management, Chemistry, Data Analysis, High Performance Liquid Chromatography (HPLC), research, cro
Clinical Research - 3 Years of Experience - Near 60626
Healthcare professional with training and experience in clinical research monitoring seeking a Clinical Research position to coordinate, monitor and manage clinical trials while safeguarding the rights and welfare of clinical trial patients by complying with the ICH-GCP guidelines, FDA regulations, Study
Tags for this Online Resume: Assessments, Clinical Research, Forth Programming Language, Good Clinical Practices, Management, Pharmaceutical, Research, Scheduling, VITAL SIGNS, Audit
Quality Assurance Specialist - 20 Years of Experience - Near 48111
Tags for this Online Resume: Assessments, Audit, IaaS, SaaS, PaaS, Infrastructure, Management, Pharmaceutical Industry, Program Management, fda regulations, part 11, Agile, HIPPAA, ISO, Project Management, Quality Assurance Manager, SDLC, Regulations, IT Quality Manager
Biologist - 19 Years of Experience - Near 27560
Summary: * 15+years of experience in instrumentation and analytical/microbiological testing. * Conducted routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy * Provided technical support and leadership as pertains to analytical/microbiological testing: verify that results are accurate and complete, recogni...
Tags for this Online Resume: ISO, Management, High Performance Liquid Chromatography (HPLC), Max, Model Driven Architecture, Scheduling, ELISA, Instrumentation, Assessments, Audit
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
Sales Representative - 20 Years of Experience - Near 19333
My objective is to obtain a position in Business Development or Sales Management in the Life Science industry.
Ideal Companies: Merck, GSK, Centocor, BMS, Millipore, Meso-scale
Tags for this Online Resume: Business Development, CRO Services, Biologics, Small Molecules, Preclinical Drug Development, Drug Discovery, In Vivo efficacy models, Preclinical R&D, ELISA, Cardiovascular, Cellular, Injections, Oncology, Research, Pharmaceutical, Business Development Manager, Cancer, Applications, Automation, Field Applications Scientist, Cell based assays
Engineering Manager - 20 Years of Experience - Near 94552
Tags for this Online Resume: Associate in Commercial Underwriting, Technical Writing, Integrate, Engineering, Instrumentation, Programming, Support, Weapons, Assessments, Automation, pharmaceuticals, validation, engineering, CSV, 21 cfr part 11, risk, protocols, GMP, facilities, medical device, FDA, ICH, EU, GAMP, change control, validation master plan, facilities master plan, aseptic processing, packaging, packaging line, WFI, clean steam, PW, SIP, CIP, process validation, critical process paramters, capital project, project management, electronic record, strategy, planning, leadership, solid dose, standards
Clinical Research - 2 Years of Experience - Near 11418
SUMMARY: * 2 years of experience in the field of clinical data management, producing data review and management objects in various clinical studies and phases in daily bases. * Coding knowledge in MedDRA and WHO Drug systems, Sound knowledge in US FDA and ICH safety reporting advices * Thorough with project set up, quality assurance, data review, data analysis, database clean up and database closing using data management sy...
Tags for this Online Resume: Pricing, Protocol, Research, Data Entry, Data Management, Management, Project Planning, Quality Assurance, Services, Support
Product Team Leader or Program Manager
My efforts span from working with Fortune 500 to incubator startups. I am well versed in regulatory models such as ISO and FDA, materials management, product development and process innovation through "quote to collect." I have re-engineered many manufacturing functions, finance and legal organiztions and I know how complex organizations work end to end. My goal is to find a company that is looking to align its organizat...
Tags for this Online Resume: product, cross funtional teams, software, hardware, engineering, Management, process engineering, DFM, MTBF, Cogs in contrast to revenue stream, Portfolio management, Critical incident interviewer, Law Enforcement, Non Profit education, law enforcement investigations, Competency modeling, management development, Corporate espionage, Team building, ISO Audits and value chain analysis, Field failure analysis, Closed loop corrective action
Sr. Manufacturing Tech with experience in Quality Assurance
SUMMARY * Strong scientific skillset acquired at academic and industry level. * 3+ years' work experience in the US Biotech industry with vast knowledge of GMP, GLP and ISO standards and regulations. * Detail oriented, diligent and ability to work in teams on multiple projects. Familiarity with 21 CFR pertaining to GMP in bioprocessing, GLP, FDA regulations and bioethics.
Tags for this Online Resume: Good Manufacturing Practices, ISO, QA, GMP, cgMP, gcp, biotech, quality assurance, GLP
Production Manager - 20 Years of Experience - Near 92703
SUMMARY OF QUALIFICATIONS A highly-dedicated and self-motivated professional with excellent qualifications in WAREHOUSE, PRODUCTION MANAGEMENT, PACKAGING MANAGEMENT, PLANT MANAGEMENT and GENERAL MANAGEMENT. Possess in-depth experience in all facets of manufacturing and packaging softgels, tablets, pills and powders. Adept at determining schedules and overseeing complex operations to ensure all production deadlines and busin...
Tags for this Online Resume: Inventory, Lean Manufacturing, Manufacturing, Policies and Procedures, Compensation, Production Schedule, Test, Kaizen, Purchasing, production, manufacturing
