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Online Resumes with "Process validation"
Scientist - 12 Years of Experience
SUMMARY * Innovation Leader - with more than 11 years of global innovation experience at The Ciba Specialty Chemicals, BASF and Nalco an ECOLAB company combined. * Broad spectrum of R&D /Innovation experience: From customer understanding to technology, formulation and product design from concept to launch. * Global, hands on experience across developed market, developing markets, and a range of discerning consumer segments....
Tags for this Online Resume: Applications, Leadership, product development, process development, process validation, tech transfer, budget, innovation, research and development, molecular design and synthesis
Chemical Process Engineer - 20 Years of Experience - Near 08816
Interested in returning to engineering work in a biotech startup. Experienced in facility startups and equipment/process validation.
Tags for this Online Resume: Chemistry, API, Manufacturing, Process, Biotech, Validation, NewJersey
Developer - 6 Years of Experience - Near 10001
SUMMARY: * Over 6+ years of experience in IT Industry with Atlassian Tools like Jira working with Complex Workflows, and Managing Plugins * Worked on JIRA Agile projects like Creating Scrum/Kanban boards, configured columns, Filters and Reports for Sprints. * Designed, built, and managed techniques for deploying specific automated builds to isolated development and built assurance environments. * Experience with Atlassian J...
Tags for this Online Resume: Git, JIRA, Applications, Configure, Linux, Management, Microsoft Windows, Structured Query Language, Troubleshooting, Confluence, jira, confluence
Engineer - 20 Years of Experience - Near 02720
Tags for this Online Resume: CAPA, process validation, process development, root cause investigation, ISO 13485, QSR / FDA CFR Part 820
Microbiologist - 20 Years of Experience - Near 45066
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Tester - 3 Years of Experience - Near 44710
PROFESSIONAL SUMMARY: * Over 8+ years of experience in IT, extended expertise in Manual & Automated Testing using Selenium web driver, Selenium grid, QTP, SOAP UI, JAVA. * Expertise in reviewing/analyzing Software Requirements Specification documents [SRS], Business Requirement Documents [BRD], creating and developing Test Plans, Test cases and test Scripts and interacting with development Team. * Comprehensive knowledge of...
Tags for this Online Resume: Agile, HP, Services, Structured Query Language, Test, Test Cases, API, Automation, ETL, Extensible Markup Language (XML)
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
Engineer
SUMMARY: Proven engineering expert with broad global experience in medical device, drug delivery, automotive, and aerospace engineering. Served roles in R&D, Product Development, Manufacturing, Quality, Validation, & Supplier Quality Engineer. Six Sigma Greenbelt. Broad domestic and global Manufacturing & Quality Engineering experience at locations in: US: Utah, Michigan, Ohio, Indiana, Wisconsin, Minnesota, New York, & Mas...
Tags for this Online Resume: Product Development, Quality, Quality Assurance, Research and Development, Six Sigma Greenbelt, Six Sigma Quality, Aerospace, Automotive, Engineering, Global Experience, DOE, IQ/OQ/PQ, FMEA, GR&R, MSA, ISO 13485, 21 CFR 820, Process Validaiton, CNC Machining, CMM Programmer, FAI, Molding, Extrusion, CAD, Toyota Production Systems, Lean Manufacturing, Medical Device, Clean Room Validation
Accountant - 18 Years of Experience - Near 11413
Professional Summary Financial Professional with years of experience utilizing Accounting knowledge to bring solutions to financial reporting, and lead projects to streamline and enhance processes for validated controls and compliance. Acknowledged for her diligence, persistence, and patience in conducting research to provide information and resolutions. Approaches tasks with a strong work ethic and an eye for details that ...
Tags for this Online Resume: MBS, Reconciliations, Automation, Capital markets, Front Office, Microsoft Exchange, Month-end Close, Accounting, ABS, CMBS
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
