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Online Resumes with "c GMP"



Clinical Quality Assurance - 15 Years of Experience - Near 27502

Tags for this Online Resume: Root Cause Analysis, ISO, Corrective Actions, Management, Policies and Procedures, Process Improvement, Quality Assurance, CAPA, Quality, Manufacturing, cGMP, CFR 21, Teamwork, Auditing, Deviation Management, SPE, ASQ CQIA, Calibration/Validation, Product Release, Direct observations, Training, MS Suites, EU Regulations, CLIA

Biomedical Engineer

SUMMARY * Extensive experience in the Pharmaceutical, Biomedical, and Semiconductor industries. * Well rounded Engineering and Business experience in Project and Operations Management, Quality Assurance, Applications, Equipment, Process, and Electronics Engineering. * Data driven, results-oriented, team-builder who strives to make significant, measurable contributions. * Thrives in complex, cross-functional, and dynamic env...

Tags for this Online Resume: Cardiopulmonary resuscitation (CPR), Diagnostic Imaging, Distribution, First Aid, Imaging, ISO, ISO 9001, Medical, NRC, Nuclear Medicine

Quality Systems Specialist - 20 Years of Experience - Near 94545

Summary * Multiple years' experience and thorough understanding of technical and business requirements for Biotech in clinical and commercial multi-product manufacturing facility. * Knowledge of regulatory expectations and requirements for protein purification facilities and industry standards and practices, manufacturing processes, cleaning validation, safety principles, quality systems, cGMPs, engineering design fundament...

Tags for this Online Resume: GMP, Troubleshooting, NPI, Change Control, Data Analysis, Management, Manufacturing, Product Development, Quality, Quality Assurance

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

Executive Director

Tags for this Online Resume: Operations, R&D / NPD, Lean Manufacturing, Manufacturing, Culture, Procurement, USDA/FDA Regs, Supply Chain, Mechincal, Food Experience, SOP's, cGMP's

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

Chemist - 15 Years of Experience - Near 60012

Tags for this Online Resume: Synthetic organic chemistry, process development, validation, kilo lab, pilot plant, cGMP, DMF, drug design and develolpment, contract manufacturing, analytical chemistry, structure characterization, new molecules development