CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA "

Biologist - 20 Years of Experience - Near 27302

Summary Results oriented individual with proven ability to learn quickly and implement problem solving methods to meet both product and process demands. Quality assurance professional with twenty three years of proven leadership skills in client management, FDA regulation adherence and defining/implementing quality system management programs. Skilled at recognizing process improvement needs and taking action to ensure FDA r...

Tags for this Online Resume: Audit, Licensing, Management, Pharmaceutical, Quality Assurance, Test, Manufacturing, Documentation, Quality, Quality Management

Laboratory Manager - 18 Years of Experience - Near 28037

Qualifications Summary Laboratory Manager with extensive experience in regulated pharmaceutical manufacturing and research and development with more than 10 years of management experience. Thorough understanding of regulated Laboratory environments including but not limited to GMP, GLP, GDP and 21 CFR Part 11. Quick learner with proven track record of driving success. Skilled at navigating FDA and vendor audits. Implemented...

Tags for this Online Resume: Project Leader, Project Management, Budgetary, Drafting, High Performance Liquid Chromatography (HPLC), Management, Planning, Rational, White Papers, clinical, phase, trial, gcp, protocol, pharmaceutical, Quality, LC/MS

General - 10 Years of Experience - Near 92612

Professional Summary Food Safety Manager/RISK MANAGER Nov. 10, 2010 /Feb. 3rd 2017 6th Street Cooling My position requirements at 6th Street Cooling: Develop and maintain a Management System that conforms to the requirements of the International Standard ISO 22000:2005 and the Global Food Safety Initiative, Organic Certification, etc. Compliance standards and Current Good Manufacturing Practice, Hazard Analysis, and Risk-ba...

Tags for this Online Resume: Forklift, Forklift Operator, Good Manufacturing Practices, Hazardous Waste, Install, ISO, Management, Manufacturing, Microbiological Testing, Risk Management, Food safety Mgr

Materials Manager

SUMMARY Global R&D Innovation Leader, 20+ years of experience in CPG food and biopharma packaging, overseeing polymer materials and packaging equipment platforms. Team leader in the introduction and commercialization of barrier coextruded structures and bioplastics in food and medical packaging. Change agent in productivity improvement, and cost reduction initiatives. Overseas assignment as Site Manager at Kraft Venezuela's...

Tags for this Online Resume: Budgeting, Inventory, Purchasing, Quality, Sourcing, ISO, Applications, Marketing Management, Packaging, Transportation, healthcare, pt

Director of Quality - 20 Years of Experience - Near 75077

Accomplished, goal-oriented leader with a comprehensive background in Regulatory Compliance and Quality Assurance. CAP, CLIA, ISO and FDA interface professional with extensive multi-industry experience in R&D, Operations, Customer/Field Service, Laboratory Operations, and Manufacturing and Supplier industries. Strong leadership abilities, with proven expertise in developing training materials utilizing the EDGE (Educate, De...

Tags for this Online Resume: ISO, FDA, AS9100, MDR, Quality System, Leader, Achiever, Assessor, Diagnostics, Manufacturing

Managing Director - 5 Years of Experience - Near 92109

Due my extensive experience in development, manufacturing and commercial release of medical devices (SW/HW solutions) following the FDA/ISO13485 and CE regulations, I'm looking for a role as a Sr.Mgr/Director in Product/Project Mgmt or Operations.

Tags for this Online Resume: Integrate, Forecasting, Business Development, Computer Aided Software Engineering, Networking, Oracle, Ethernet, Forecast, Foundry, Management, management, Product Manager, Program Manager, Project Manager

Biochemist - 20 Years of Experience - Near 95051

Professional Summary: * Superior problem solving skills, QC/QA validation, GLP protocol expert, FDA * qPCR designs, Elisa, SOP validation, Automated System Specialist, Statistical analysis * HPLC, Flow Cytometry, Chromotography, Analytical Chemistry, Sample preparation and Analysis

Tags for this Online Resume: Research, Filing, Packaging, Product Launch, Protocol, Allergy, Analytical Chemistry, Applications, Biomedical Industry, Chemistry

Pharmacist - 2 Years of Experience

Familiarity with FDA regulations, standard operating procedures (SOPs), good programming practices (GPP). * Utilized MedDRA and WHO-DRUG dictionaries in creating summary tables for Adverse Events and Concomitant Medications respectively.

Tags for this Online Resume: Information Technology, Coding, Data Migration, Distribution, Documentation, Programming, Project Management, Project Manager, SAP, SAS

Director - 20 Years of Experience - Near 08520

ACCOMPLISHMENTS * Lead client teams and CDMOs in Product Risk Assessments, EHS Analyses, Regulatory Audits, FDA PAI readiness program, interfaced with US Environmental Protection Agencies for new and updated Air Emission and Wastes Water Effluence permits. Manage OSHA training and audit programs. Reduced product technical and compliance risks while saving safety-related operating cost by reducing planned budget by >10%. Ben...

Tags for this Online Resume: Engineering, Manufacturing, Compliance, ECMS, HVAC, Infrastructure, Material Handling, OSHA, Business Development, Management, director, consultant, regulatory compliance

Life Scientist - 20 Years of Experience - Near 30523

QA Manufacturing Compliance Lead Lead QA Validation Remediation - Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products. Conduct review of CMO validation change control and QC OOS/OOT reports and write annual Product Review for all produ...

Tags for this Online Resume: Training, Project Management, Distribution, Management, Risk Management, CFR Part 11, Design Specification, pharmaceutical, protocol, Leadership, Staff development, cleaning validation, process validation, computerized systems validation, Program Management, QC testing, Chemist, CAPA, NCR, Customer Complaints, Supplier Quality, commissioning, equipment qualification, equipment purchase, Change control, Auditing, Medical Devices class I, II and III, Pharmaceutical development DOE, Pharmaceutical Clinical Scale-up, Mfg./Pkg. Management, ISO13485, Technical Reporting, FDA site QA contact

Clinical Research - 20 Years of Experience - Near 91354

QUALIFICATION SUMMARY Multi-center clinical trial Staff management and Budget development and fiscal research contracts development management Nationally recognized in Proposal & grant writing Revenue generation contraceptive development Contract negotiation International partnerships Federal regulatory compliance Fiscal oversight including Board of Directors relations, Multimedia recruitment company 401K and space committe...

Tags for this Online Resume: Evaluate, Gynecology, Obstetrics, Publications, Clinical Research, Research, clinical, phase iii, phase iv, phase i, clinical trials, research, cro, regulatory, phase ii, pharmaceutical

Quality Assurance Specialist - 13 Years of Experience - Near 08540

Professional Summary More than 14 years of experience in Pharmaceutical and Life Sciences Industry with key focus in Business Requirements Analysis Data Analysis and Management Software Application Testing Document Management Change Control and Release Management FDA Compliance Verification and Validation Quality Assurance Processes and Methodologies Developing Testing Strategies and Test Plans Test Scenarios and executing ...

Tags for this Online Resume: Test Scripts, Test, Management, Test Cases, Structured Query Language, Audit, CFR Part 11, Test Plan, Application Server, Documentation, validation of protocols