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Online Resumes with "21CFR Part 11"



Position as a Senior Information Technology professional using my experience in personnel and project management leading IT services for the development and production of software products.

Senior level experience in product lifecycle: personnel management (client & team), project planning, budgeting, requirements and analysis, design, risk management, coding / manufacturing, quality assurance, systems integration, validation & verification, release, support, maintenance, and auditing.

Ideal Companies: Sun Microsystems, McKesson, IBM

Tags for this Online Resume: Director, Manager

Cross functional thinker and cross cultural team player

I thrive on learning new things and constant changes. Leading edge does not turn me away. Currently working in Switzerland and seriously looking to relocate to Asia for good opportunity.

Ideal Companies: Google, Nintendo, Goldman Sachs

Tags for this Online Resume: PMP, Big five, 21 CFR Part 11, GCP, GMP, CSV, Biotech, Clinical study planning and forecasting, Clinical investigator portal

Grand Rapids MI Business Intelligence Systems Programmer Analyst

Looking for a position where I can continue helping companies better utilize their technology by developing/enhancing processing or business intelligence applications or in a business/system analyst role.

Tags for this Online Resume: programmer, analyst, business intelligence, data warehouse, sap bw, sap bi, legacy, cobol, cognos

Quality Laboratory Manager and Lab Informatics Project Manager - 13 years of experiece at Johnson and Johnson

- Project Manager/Business Analyst in Lab Informatics - Laboratory Manager/Supervisor

Tags for this Online Resume: LabWare LIMS, People Leadership, Project Leadership, Business Analyst, • Quality and Customer Advocacy, • Computer Validation and Risk Analysis, • Training and Curriculum Development, Six Sigma, 21 CFR Part 11

FDA compliance consultant

Started as a research assistant for a company that markets specialty clay for additives in polymers. Was listed as inventor on three patents. After a short assignment at a food company, moved into validation and quality work in the pharmaceutical industry.

Ideal Companies: Abbott, Baxter, Takeda, Hospira

Tags for this Online Resume: validation, cGMP, 21 CFR part 11, Part 820

Sales Executive

Looking for sales or account management in the scientific vertical. I have over 15 years selling into Life Science, Pharmaceutical, Government, Educational and Chemical markets. Technical ability to sell complicated enterprise software to "C" level management. I take a consultative approach and would be considered a Hunter in the sales process.

Tags for this Online Resume: chromatography, Scientific Software, Scientific Distribution, HPLC, Life Sciences, 21 CFR Part 11, Validation, serevices, bio informatics, informatics, SDMS, technology, sales, hunter

Software Quality Specialist - 8 years experience

Results-oriented with reputation of critical quality analysis and enhancing customer satisfaction. Effective in streamlining processes to speed project deliverables.

Tags for this Online Resume: Software testing, Technical writing, Creative, Lean process, Quality, SDLC, Functional testing, Regression testing, 21 CFR Part 11, GMP, pharmaceutical, bug tracking

Analytical Chemist, James J. Bradford, Ph.D.

I am interested in obtaining a position in a team environment that will utilize my knowledge of Analytical chemistry, biochemistry, and computer systems and software. During my last several positions I was hired for six month contracts and had each position extended to eighteen months. Most recently I have been involved in the training of users in SmartLab at Eli Lilly. This included the instrument connections and scripting...

Application Support

Tags for this Online Resume: Robohelp, Framemaker, Word, 21 cfr part 11

Featured Profile

IT Professional - Versitle Expertise

IT professional with extensive experience in manufacturing across diverse industry sectors including medical devices and healthcare, non-profits and both mid-size and large companies including a Fortune 500 biotechnology company.

Ideal Companies: Large To Mid

Tags for this Online Resume: RPG ILE, DOS, DOS 5.0, DOS 6.2, Windows 3.0, Windows 3.1, Windows 95, Windows 98, Windows 2000, Windows XP, Windows 7, MS Offfice 2003, MS Offfice 2007, MS Offfice 2010, Lotus Notes, OutLook, Rockwell, Vision Systems, FDA, ISO, CFR 21 Part 11, SOX, Risk Managerment, Visual Basic, Avaya, MS Server, Rumba, AS 400, PEAK, RF, REMEDY, Peregrine, Project Management, KBO, KPI, SLA, SOA, Asset Manaagement, Manufacturing Support, Crisis Management, On Call, Remote Access, SMS, Travel, Relocation, Health Care, Distribution, Global, SDLC, Security, Flexibility, Customer Service, Automation, CLP, Diasaster Recovery, IBM, Contracts, Billing, Finance, Human Resources, Research Development, Testing, Validation, KeyTroller, Network, M-LAN, Anti Virus, Operating System, Wireless, Laptop, Desktop, Support, Acquisition, Outsource, Help Desk, Service desk

Compliance Manager/Auditor

To obtain a position working as a Microbiology Business Analyst and Project Manager in a pharmaceutical/biotech validation environment, oriented toward management advancement. Over 20 years of experience in the Pharmaceutical Industry, 16+ years of those years are with GxP (GMP, GLP, GCP) systems compliance/QA and 21 CFR Part 11. Experience includes GxP system implementation projects, documentation/SOP writing/review.

Project Manager

Edward Koza, Jr. 10 Whittier Road Clark, NJ, 07066 Home - (732) 381-4389 Cell – 732-694-9073 E-mail – edjet21jr@hotmail.com Re: Sr. Manager/Asst. Director Prior to the sale of the Pharmaceutical Technologies & Services, a division of Cardinal Health I was Director of the Global Application Support Team. Together we were responsible for 528 applications that made up of the main ERP applications, SAP (for Distr...

Tags for this Online Resume: 21CFR Part 11, GXP GMP, Sox FDA, SiX Sigma Green Belt, PMBOK, Oracle/ SAP