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Online Resumes with "FDA Audit"
Quality Specialist
Analytical chemist position with a solid, well-established company within an environment conducive to continued personal and professional growth in the field focusing on: method development; method transfers; validation; writing of protocols and SOPs; instrumentation(HPLC, IC, GC, AA, IR, NMR, MS, GC-MS, LC-MS).
Ideal Companies: Biogen Idec, KBI, Novo Nordisk
Tags for this Online Resume: Method Development, Method Transfers, GMP/GLP, Validation, HPLC, GC, IC, AA, GC-MS, LC-MS, TOC, Conductivity, Project Management
Clinical Research - 14 Years of Experience - Near 37601
Tags for this Online Resume: Management , Time and expense report review and approvals, , Home office, Matrix reporting structure , Quality assessments, Budgeting, Successful FDA Audit-Clinical Regulatory Affairs/, Board Member --Treasurer ACRP Chapter in North East Tennessee Region
Production Manager - 15 Years of Experience
My name is Edna Torres, honest, respectful, responsible and committed. Excellent experience as Manager in different operations areas, as sterilization, packaging, inspection, compounding, sterile processes as filling and clean rooms sanitation. Contract manufacturing partnership, different types of medical devices and others.I'm confident that I can met your requirements as an experienced professional. Thanks for the opport...
Tags for this Online Resume: sterilization, sterile filling and compounding, biological products, CAPA, continous improvement, FDA audit, Packaging, automatic and manual Inspection
Quality Manager - 15 Years of Experience - Near 28451
Summary of Qualifications Extensive managerial/supervisory experience. QA/QC and Regulatory Compliance expert, intimately involved in all aspects of QA/QC laboratory production. Vital member of key cross-functional teams. A highly motivated, self-starting executive, analytical scientist and quality expert with excellent organizational and leadership skills. Noted as a consistently strong and productive team leader, who can ...
Tags for this Online Resume: Quality expert, Analytical Scientist, GMP/GLP, ISO/FDA Audit Expertise , ICP-MS, GC, HPLC, Wet Chem, Pharma Mfg, Documentation, QA/QC, Test, Complaints, Corrective Actions, Quality, Quality Assurance, Compliance
Clinical Research
Summary of Qualifications Clinical Research Manager, Associate, Monitor, Coordinator, with over 25 years experience in the medical field and 21 years experience in clinical trials with extensive experience in the fields of Cardiology, Electrophysiology, Neurology, Urology, Autoimmune, Respiratory, Gastroenterology, Weight Loss, Diabetes, Women's Studies, Arthritis, COPD, Gynecology, Endocrinology, Rheumatology and Stem Cell...
Tags for this Online Resume: Monitoring, Protocol, Cardiovascular, Clinical Research, Management, Pharmaceutical, Research, Therapy, Audit, Data Management, Medical Device, CRA, CTM, Clinical Trials
Chemist - 15 Years of Experience - Near 44131
Summary of Qualifications Motivated, talented and disciplined Quality Manager with wide-ranging experience leading laboratories and cross-functional project teams. Extensive technical experience with good working knowledge of online services. Adept at learning and applying new concepts. * Project Management * Staff Management * Stability Guidelines * Strategic Planning * Final Product Testing * Chemical Processes * Budgetar...
Tags for this Online Resume: Compliance, Chemistry, Quality, Quality Assurance, Quality Control, Management, Problem Solving, Product Development, Project Management, Services
Clinical Research - 15 Years of Experience - Near 92880
ACCOMPLISHMENTS * Worked with 50 different sponsor and CRO companies on various GI studies * Managed Bunion investigational study with 300 patients. * Three FDA audits without 483. * Met all recruitment targets within required study timeframe * Managed regulatory binder for studies, post start-up * In depth knowledge of Microsoft packages ( Word, Excel and power point) Experienced with Oracle, Inform, Medidata eDC programs ...
Tags for this Online Resume: Clinical Research, Oncology, Research, Computer Aided Software Engineering, Good Clinical Practices, Medical, Microsoft, Microsoft Excel, Microsoft PowerPoint, Microsoft Word
ERP - 9 Years of Experience - Near 19341
Profile Lead Management for SAP Security and Compliance Strategies. Experience with all types of business, both Private and Public Sector, Manufacturing, but with a concentration in the pharmaceutical Industry. Work with both internal/external auditors, SOX audits requirements, along with FDA audits. Able to lead teams of various sizes. SAP Experience - Summary Project lead for Security and SOX Compliance for variety of SAP...
Tags for this Online Resume: User Administration, Audit, Information Technology, R3, SAP Security, SAP R3, Compliance, Monitoring
Admissions Director - 15 Years of Experience - Near 10567
I have worked in the records management area of the pharmaceutical industry for 14 years. My experience includes working on projects, three years of managerial experience and helping staff deal with FDA audits.
Tags for this Online Resume: Filing, Distribution, Management, Medical, Medical Records, SAP, Appraisals, Custody, N?mecký jazyk, Spring, healthcare
Chemist - 4 Years of Experience - Near 55401
Professional Summary Experienced Assitant Analyst aimed to grow with a leading organization that utilize my abilities to the fullest extent possible, helping me realize and develop my potential and be a part of a team that scales great heights through continuous learning process and utmost dedication. Areas of Expertise * HPLC * UPLC * GC * Dissolution * Autotitrators * UV spectrometer * pH meter * Thermocycler * ELISA, RIA...
Tags for this Online Resume: Corrective Actions, pH Meter, Root Cause Analysis, Management, Test, Water Treatment, ELISA, English Language, High Performance Liquid Chromatography (HPLC), Hindi Language
Department Manager - 20 Years of Experience - Near 94589
Manager with extensive experience managing the Pharmaceutical industry. Strong knowledge of cGMP's. Outstanding record of success in FDA audits and maintaining world class inventory accuracy with WIP, Finish Goods, and Raw Materials inventories. Excellent track record in motivating, challenging and keeping employees educated and in compliance.
Tags for this Online Resume: HR, Human Resources, Inventory, Distribution, IBM, Rf, Root Cause Analysis, Inventory Control, Retail, Forklift, manufacturing, reliability, production, "project management"
Supply Chain Manager - 20 Years of Experience - Near 55337
I am a Logistics professional who is capable of managing logistics, supply chain, regulatory concerns and operations functions by utilizing a variety of resources. My expertise is in executing any and all tasks presented and necessary to successfully maintain high customer satisfaction expectations. Through my comprehensive history of increased professional scope and skills learned, I am thoroughly prepared for any logis...
Ideal Companies: Cargill, UTC Aerospace Systems, General Mills
Tags for this Online Resume: Logistics, Supply Chain, International Trade, Import / Export, Air Freight, Ocean Freight, Transportation, SAP, JDE, OTM, Freight, Microsoft Office
