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Online Resumes with "FDA"



Biotechnical Equipment Sales Representative - 20 Years of Experience

SUMMARY OF QUALIFICATIONS Excellent qualifications relating to Sales, Business Development, and Management have been produced through 19 years of extensive professional experience and advanced training. * Successful track records of providing leadership and influence over administrative, public relation, market research, information analysis, sales forecast, negotiation, market development, business solutions, delivery, lif...

Tags for this Online Resume: Forecast, Sales, Training, Business Intelligence, Email, Purchasing, Pulmonary, Pricing, Business Strategies, Arabic Language

Medical & Clinical Laboratory Technologist - 10 Years of Experience - Near 30087

QUALIFICATIONS Blood Banking * Hematology * Chemistry * HIV Testing * Herpes Antigen Testing * Toxicology * Serology * Syphilis Testing * Cytomegalovirus (CMV) * Quality Control Experience * Quality Assurances * Procedures & Documentation * Knowledge of CAP, CLIA and FDA Compliance and Guidelines * Lab Testing & Reporting.

Tags for this Online Resume: Compliance, Documentation, Good Laboratory Practices, HIV/CMV/ABO/Rh, Medical Analysis, Occupational Safety and Health Act, OSHA, OSHA Regulations, Quality Control, Chemistry

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

Project Manager

A position that can leverage my experience managing large, complex IT environments that require adherence to process while building excellent customer partnerships and strong internal teams. - Project Design and Management - IT Infrastructure Deployment - Issue Management and Mitigation - Proactive Client Relationships - Large IT Project Deployment - Budget Creation and Management - Process Creation and Documentation - Chan...

Tags for this Online Resume: Data Center Services, Services, Itil, Project Management, Project Manager, Customer Relationship Management, Documentation, Infrastructure, Inside Sales, Professional Services

Business Analyst - 7 Years of Experience - Near 08817

Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...

Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project

Chemical Engineer - 14 Years of Experience - Near 77004

SUMMARY Over 7 years of diversified international experience in the Engineering sector including pharmaceuticals, oil and gas and power plants. Well-qualified to contribute in Pharmaceutical environment from Lab, Pilot Plant to FDA-compliant production. Experienced in both batch and continuous processes. Experienced in execution of validation processes, Temperature Mapping & knowledge in validation testing (IQ, OQ, PQ, RQ, ...

Tags for this Online Resume: IDS, Engineering, Evaluate, Manufacturing, Quality, sheets, Audit, Autocad, Autodesk AutoCAD, Automation

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

Administrative Assistant - 20 Years of Experience - Near 95115

Summary Candidate has extensive contract experience, due to family obligations, and she is presently looking for full-time employment. The candidate has worked in areas ranging from procurement, accounting, logistics, document control, office operations, inventory control and real estate. Additionally, the candidate has the ability to develop and build critical relationships with internal, as well as external customers, con...

Tags for this Online Resume: Purchase Orders, MRO, Purchasing, Audit, Document Control, Microsoft Excel, Quick Books, Quickbooks, Accounting, Accounts Payable, PeopleSoft

Clinical Quality Assurance

SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...

Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API

Operations Manager - 10 Years of Experience - Near 77494

Tags for this Online Resume: cGMPs, FDA, Manufacturing, Process Improvement, Cleaning Validation, Six Sigma, 5S, Lean Manufacturing, JD Edwards

Director of Quality - 15 Years of Experience

SUMMARY Certified Quality Auditor for Life Science Practice Lead as senior Quality System Auditor with compliance acumen delivering outstanding returns through comprehensive knowledge and hands on experience. Vendor qualification and management plus remediation efforts ensuring delivered products meet requirements for direct to stock fulfillment. Certified Quality Auditor/Project Manager for Quality Management Systems for m...

Tags for this Online Resume: Audit, Quality, Quality Assurance, Services, Test, Compliance, Infrastructure, Management, Risk Management, Training