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Online Resumes with "CFR part 11"



Biologist

Seeking a position to utilize my knowledge, skills, and abilities in the industry that offers competitive environment, and gain exposure to upcoming technologies while being resourceful, innovative and flexible. Hands-on experience in DNA and Protein isolation, Purification, SDS-PAGE, Cloning, Mammalian Cell Culture, Transfection, HPLC, PCR, RT-PCR, IVD Assay Development, NGS Data Analysis, Western blot, Immunohistochemistr...

Tags for this Online Resume: Documentation, Research, Assessments, CFR Part 11, Chemistry, Distribution, Electrophoresis, ELISA, High Performance Liquid Chromatography (HPLC), Immunization

Quality Assurance Specialist - 6 Years of Experience - Near 75093

SUMMARY * Experienced with Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). * Experienced in Agile and Waterfall environments. * Experienced in using HP interactive products like -HP Quality Center (ALM/QC) and JIRA. * Good exposure to Web technologies like HTML, XML and JavaScript. * Experience in SQL queries and Joins (Inner/Outer) to validate data. * Experience in IVR/IWRS Testing. * Experie...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server, sql, java, javascript, agile, html, software

Laboratory Technician - 15 Years of Experience - Near 46038

Tags for this Online Resume: Management, Good Manufacturing Practices, Manufacturing, Consulting, Documentation, Microbiology, Software, SAP, Audit, CFR Part 11

Computer Programmer - 20 Years of Experience - Near 33156

Hi, I wrote the BEST GUI for Angular 2 Mobile App Frame called SwipeClouds that is SUPERIOR to Ionic – Read My Article About It: https://www.codeproject.com/Articles/1175045/Angular-Mobile-App-with-JQuery-Mobile-Cordova-or-P Previously I developed software for Microsoft as their Director of Live Search Marketing & Software Development. And at MySpace.com I was their Director of Software Development. I work with the lates...

Tags for this Online Resume: jQuery, Microsoft, Microsoft Windows, Blackberry, Hyper Text Markup Language 5, Marketing Management, Project Leader, Video, Security, Software, linux, it jobs, c++, html, agile, c#, software, javascript, java, sql, PhoneGap, HTML5, Angular, Angular4, Angular2, Angular 5, JQuery, Mobile, Java, Objective C, SwipeClouds Framework, Canvas, CTO, Director, .NET, VB .NET, Angular 1.4, React

Manager - 20 Years of Experience - Near 46033

Summary of Qualifications: Senior hands-on IT Manager with successful record of accomplishments in IT infrastructure management, data center design, security, and virtualization. Ability to rapidly align with mission critical initiatives, envision enterprise-wide solutions, deploy cost effective methods, and engaging high performing talent to exceed expectations. Recognized for strength in areas of team building, motivation...

Tags for this Online Resume: Lan/Wan, Lead Generation, Leadership, Local Area Network, Wide Area Network, Active Directory, CFR Part 11, Cisco, Cisco PIX Firewall, Firewall

Biological Technician - 18 Years of Experience - Near 02421

SUMMARY Quality Control Chemistry works, Internal/External Audits and Inspection, Maintain Laboratory update with Quality Management. Technical work and knowledge of Biotech/ Pharmaceutical QC/QA system with cGMP and GLP compliance, Practice Quality Management and ICH regulations guided by ISO 9000+. Complete COA for drug product and biologics. Maintain liaison with contract manufacturing (CMO/CTL) Operation and collect bat...

Tags for this Online Resume: CFR Part 11, Inventory, ISO, ISO 9000, Troubleshooting, Audit, Change Control, Chemistry, Documentation, pharmaceutical

ERP - 20 Years of Experience - Near 47630

Summary of Experience and Qualifications * SAP Transformation professional with more than ten years of SAP experience (3 full life cycles), in Consumer & Pharmaceutical Products * Strong Project Management experience in managing multiple medium to large SAP projects ($1 million - $4.5 Million), forming & performing large teams through various stages * SAP Max Attention management, SAP custom engagements: o Success Factors, ...

Tags for this Online Resume: Software, Application Architecture, Management, Pharmaceutical, Business Management, software, SAP, HANA, CONSUMER PRODUCTS

Project Manager - 15 Years of Experience - Near 27519

SUMMARY Senior Project Manager with 15 years of experience in managing IT projects for firms across U.S and Asia. Involved in managing client & vendor relationships, development and support teams working in global/virtual working environment with onshore, offshore and multi-location delivery models. PMP Certified Practitioner aiming to leverage my considerable experience and efficiency expertise into your project manager ro...

Tags for this Online Resume: Management, Support, Acquisitions, CFR Part 11, Data Management, Integrate, Itil, Legacy, Manufacturing, Planning, agile, java

Quality Assurance Specialist - 7 Years of Experience - Near 75093

Professional SUMMARY * Over all 7 years of experience in the IT industry in Quality Assurance using Web based and Client/Server applications. * Knowledge of Healthcare, Pharma, Security and Biometric projects. * Key expertise includes testing Extensive experience in Manual and Automated testing using Selenium and defect tracking tools like HP Quality Center (ALM/QC), Bugzilla, JIRA and Bug Zero. * Conversant with all phases...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server

validation/quality/manufacturing engineer

PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...

Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing

Project Manager

Tags for this Online Resume: Management, Project Management, Project Manager, Legacy, Manufacturing, Automation, CFR Part 11, Compliance, Documentation, Health Insurance Portability And Accountability Act

Statistical Programmer - 5 years Experience - US

Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...

Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test