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Online Resumes with "Part 11"



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

Supervisor

Mr. Thomas M. Golden is a Senior Validation Engineer with 25 years of experience in the pharmaceutical and biotech industries. Mr. Golden has extensive experience in both management and team player roles in utilities process development scale ups technology transfer cGMP GDP SOPs FDA regulations and critical utilities. He has excellent oral and written communication skills and is an innovative leader who believes in teambui...

Tags for this Online Resume: Manufacturing, Procurement, Utilities, Packaging, Protocol, Acceptance Testing, Management, Pharmaceutical, manager

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

Microbiologist

Ideal Companies: KeyTekh LLC

Tags for this Online Resume: CFR Part 11, Chemistry, Government, Inventory, Quality, Quality Assurance, Quality Control, Research, Support, Audit