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Online Resumes with "cgMP"
Biologist - 13 Years of Experience - Near 07208
Qualifications Summary Highly competent, diligent, and detail-oriented management professional, equipped with extensive experience and expertise focused on various areas of quality improvement, process validation and qualification, manufacturing, risk analysis, as well as implementation of standard procedures and policies within the pharmaceutical industry. Possess solid instrumental analysis skills and expertise in categor...
Tags for this Online Resume: Management, Complaints, CFR Part 11, High Performance Liquid Chromatography (HPLC), FDA, New Jersey, MSDS, Policies and Procedures, Process Improvement, Protocol, CAPA
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
Biochemist - 14 Years of Experience - Near 92606
PROFILE Experienced Project Scientist/Manager with strong background in neurodegenerative diseases, vaccine development, protein expression, analysis and production. A seasoned expert in animal models of neurodegeneration, protein biochemistry and cGMP manufacturing. Excellent team player and communicator, able to meet ambitious goals while successfully working in a matrix organization. Possess significant experience in pla...
Tags for this Online Resume: Manufacturing, cGMP, Documentation, Conferences/Events, Project Management, Research, Cancer, Protein Biochemistry, Biologics, Budgeting, Animal models, Neurodegenerative diseases, Drug development
QA - 20 Years of Experience - Near 39426
Pharmacopeia upgrade monograph tests for Dimethyl Sulfoxide. * Monitor and update USOSHA and foreign country SDS sheets and product label / placard required for a wide array of products. * Played an integral role in securing the EU Certificate of Suitability (CEP) for Procipient Dimethyl Sulfoxide in 2014. and Health Canada Drug Master Files (DMF) for Dimethyl Sulfoxide to ensure compliance and enhance clarity. Maintained r...
Ideal Companies: 1 month -
Tags for this Online Resume: Audit, Pharmaceutical, Quality Assurance, Test, DMS, Dms (Data Mgmt Tool), QA/QC, ISO, Management, Instrumentation
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
Clinical Regulatory Affairs - 4 Years of Experience - Near 02494
SUMMARY * Current graduate student working on second master's degree in Regulatory Affairs for acquiring general insights of regulatory profession and in-depth practical knowledge of regulatory compliance, including CMC (Chemistry, Manufacturing, and Controls) and quality system practices. * Extensive background in the biopharmaceutical industry and 3-year experience in upstream bench-scale cell culture process development ...
Tags for this Online Resume: Biopharmaceutical, Biotechnology, ICH, Regulatory Affairs, Manufacturing, Medical Devices, Regulatory Compliance, quality assurance, FDA, EU, Pharmaceutical, GMP
Quality/Research Manager - 20 Years of Experience - Near 01020
Management of technology and staff are my strongest suits. As a patented research scientist I developed products from concept to customer in the polymer industry.I have had staffs of professionals and hourly working with me. ISO cGMP FDA experience and more I believe in utilizing outside of the box techniques to make major improvements and eliminating the costs associated with step changes. Last experiment first!
Tags for this Online Resume: Adhesives , Quality Manager, Technical Sales, Technical Services, Marketing, AS9100, Right sizing, Consulting, CMM (Capability Maturity Model), Dialysis, FORTRAN, Fortran Programming Language, Mts, Mts (Microfocus Trans), Pc, Personal Computer
Quality Coordinator - 15 Years of Experience - Near 33311
Qualifications 12/2005 - 09/2016 Watson Labs/Actavis/Allergan/Teva Davie, Sunrise and Weston, FL Senior Controlled Substances Coordinator / Site DEA Compliance Specialist Compiled data, accurately complete and submit quarterly ARCOS and Year End Reports by established due dates. Continuously monitor the receipt of Controlled Substances and List 1 Chemical materials purchased to ensure the Quota is not exceeded. Continuously...
Tags for this Online Resume: Audit, Compliance, Distribution, Documentation, Inventory, Manufacturing, Packaging, Controlled Substances, Policies and Procedures, Licensing
Production Supervisor
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Scientist - 15 Years of Experience - Near 30045
PROFESSIONAL SUMMARY * Result oriented, Creative, Passionate, highly focused, experienced Pharmaceutical R&D Scientific Lead with good ethics, possessing over 15 years of experience in Formulation design, Process Development, Optimization and Scale up of various Pharmaceutical Dosage Forms, Solid Orals (IR and ER Tablets and Capsules), Liquid Orals (Solutions, Syrups and IR / ER Oral suspensions), and Parenteral formulation...
Tags for this Online Resume: Product Development, Filing, Pharmaceuticals (Generics), Formulation Research, Management, Budgetary, Process development, Oral solid dosage forms, Manufacturing, ANDAs
