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Online Resumes with "fda regulations"
Department Manager - 20 Years of Experience - Near 00693
Professional validation expert and scientist with up to thirty years of overall experience in the Pharmaceutical Medical Device and Biotechnology Industry. Proficient in manufacturing industry environment including but not limited to facilities utilities solid dosage equipment HVAC water systems chemical plant equipment chemical biotechnology and microbiology instrumentation handling validation (IQ OQ PQ) validation plans c...
Tags for this Online Resume: Quality, Quality Assurance, Project Leader, Project Management, Support, Manufacturing, Test, High Performance Liquid Chromatography (HPLC), Injection Molding, Instrumentation
Quality Engineer
SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.
Tags for this Online Resume: Packaging, Manufacturing, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Quality Control, Training
Quality Manager - 20 Years of Experience - Near 27529
SUMMARY I am a highly experienced Quality Engineer/Manager, who possesses the ability to enhance all aspects of my company's operations. Through sound and consistent processes, I have reduced cost, manpower, downtime, cycle times, and product rejects, while improving internal and external communication, customer satisfaction, and quality processes and products to further the organization's initiatives over broad business av...
Ideal Companies: Novo Nordisk, Grifols
Tags for this Online Resume: ISO, ISO 9001, Training, Complaints, Protocol, SPC, Black belt, Clean Room, Plastics, Product Development
Business Analyst
Professional Profile Summary Department Manager (Accounting and Systems) - Accounting and Systems Department Head for a Community Development Non Profit and Hospital responsible for Accounting, Payroll, Accounts Payable, Accounts Receivable, Investment Portfolios, Cash Management, Reimbursement and Budget Planning and Management. Along with the management of the day to day planning and operational systems, in both cases I w...
Tags for this Online Resume: Payroll, Budgeting, General Ledger, Business Analysis, Business Analyst, Information Technology, Quality, Quality Assurance, SAP, Insurance
SENIOR PERSONAL CARE PRODUCTS CHEMIST WITH 15 YEARS OF EXPERIENCE IN FORMULATION, TESTING, AND REGULATORY STANDARDS
Applying my Education and Experience in Every Possible Way to achieve the Maximum Profitability and lowest Cost Possible to the Employer
Ideal Companies: Johnson and Johnson, Proctor and Gamble, Unilever, Colgate - Palmolive
Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), OTC, Quality, Chemist, Formula, Personal Care, Cosmetics, Household, QC, R & D, FDA, Consult
Department Manager - 20 Years of Experience - Near 92058
Results-driven engineering, plant management professional with broad-based experience planning and leading plant operations within large-scale cosmetic manufacturing and packaging in FDA regulated environments. Solid track-record devising, evaluating, and implementing continuous process improvements minimizing waste and reducing costs while maximizing quality and yield. Establish effective quality control and safety program...
Tags for this Online Resume: Maintenance/plant management, Install, Lean Manufacturing, Manufacturing, Packaging, Policies and Procedures, Cms, Defense, Kaizen, Light Emitting Diode
Clinical Quality Assurance - 0 Years of Experience
Executive Profile Summary I have for over 25 years acquired a vast knowledge in cGMP, Quality Management Systems, and Quality & Compliance in the areas of Pharmaceutical / Biotechnology / Biologics / Chemical Product Development / Quality Assurance & Control, and Food and Chemical Industries (which includes Food & Consumer Goods), (Industrial Retail & General Manufacturing ). My detail-oriented critical thinking creative-pr...
Tags for this Online Resume: Quality, Quality Assurance, Management, Test, Consulting, Engineering, Pharmaceutical, Protocol, QA/QC, Acquired Immune Deficiency Syndrome (AIDS)
Clinical Research Project Manager Interested in Growing with a Patient Centered Organization
My career goal is to first obtain a clinical research project manager position with an innovative, patient-centered pharmaceutical company, medical device company, clinical research organization (CRO), or medical center. Eventually, I would like to prepare to segue into international development as a Senior Director and play an integral role in developing a research infrastructure for new companies and/or those interested ...
Ideal Companies: Pfizer, AstraZeneca, Becton Dickinson, etc.
Dedicated healthcare professional
Dedicated healthcare professional with 14 years of clinical, administrative and management experience, including 6 years as a Clinical Research Coordinator and 14 years as a Medical Assistant. Combined clinical skills and business acumen. Excellent communication and interpersonal skills. Master of Science in Clinical Research Administration degree.
Ideal Companies: Clinical Research
Tags for this Online Resume: Recruiting, Microsoft office, Liaison, Employee Development, Clinical Research Coordinator, Medical Records, Healthcare Administration, Management, Data Collection, Analysis, Medical Terminology
Developer - 18 Years of Experience - Near 37921
Solutions for computer networking, mainframe, and client/server applications associated with various industrial and commercial enterprises. Extensive knowledge of industry related standards, codes, and guidelines with ability to apply knowledge into practical applications, with extremely strong troubleshooting skills. Extensive knowledge of regulated environment requirements, including FDA, German Health Authority (GHA), a...
Tags for this Online Resume: Management, Pbx, Point Of Sale (Pos), Software, Software Development, Switches, Video, Accounting, Debugging, Applications
DIRECTOR OF SOFTWARE ENGINEERING
Highly skilled Software Product Manager with more than twenty years of progressive development experience. Proven Agile program/project management and coaching experience in software engineering and ecommerce/marketing. Skilled IT systems manager providing software engineering leadership to development teams for software testing, requirements definition and analysis. Solid development expertise for software products includ...
Ideal Companies: Digital River, Sapient Nitro, Amazon, Target, Overstock.com, AutoDesk, Disney World Parks and Resorts Online, Adobe, InfusionSoft, Apollo Group, US Airways, American Express
Tags for this Online Resume: Project Management, Program Management, Agile, Lean Six Sigma, Java, Python, SQL, HTML, Javascript, C, Rally, Jira, TFS, Windchill, Jenkins, Selenium, Microsoft Office, Rational Team Concert, AccuRev, Linux, UNIX, Microsoft Windows, iOS, SDLC, Test Driven Development (TDD), Scrum, Kanban, SaaS, IT Governance, e-commerce, Automation, Vendor Negotiation, Story Mapping
Pharma/Drug Safety (Research, Development)
Highly experienced, trained research and drug safety professional with extensive knowledge of FDA, EU and ICH regulations necessary to develop, study, and market medical drugs and devices. Public health professional with over 15 years of proven experience as a general physician, direct outpatient care and emergency medicine provider. Passionate about global health and drug safety. Adept in research, grant writing, public he...
Ideal Companies: Abbott, Medix, PRA health sciences, Catawba Research, Medpace, Acelity, Bellicum Pharmaceuticals, Covance, US Prahs, Novartis, Bayer, Integrated Resources INC, The University of Texas Sothwestern, Baylor Scott & White Health, Abbvie
Tags for this Online Resume: Public Health, Clinical Research, Data Analysis, Pharmacovigilance, FDA regulations, drug/device research and development, clinical trials, risk management, regulatory compliance, French language, Spanish language
