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Online Resumes with "part 11"



Programmer Analyst

SUMMARY * 6 years of experience as a Statistical Programmer in Clinical trials of Pharma Industry. * Expertise in SAS programming features like BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and ODS. * Skilled in generating reports featuring various SAS procedures, like Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, Proc Datasets, Proc Compare, Prco SGPLOT, and Proc SQL. * ...

Tags for this Online Resume: Base SAS, Macro (Predefined Code), Proc, SAS, SAS/STAT, Statistical Analysis, Structured Query Language, Data Analysis, HyperText Markup Language, Microsoft Excel

Quality Assurance Specialist

Summary A Quality Assurance Analyst with extensive experience in a variety of job sectors. Self-motivated professional who is recognized for integrity, contributions to cross-functional teams, detail orientated and a continuous improvement mindset. Possesses skill and knowledge in the following: ISTQB Testing Certification 2008 HIPAA Certification 2014 SDLC Methodology Agile Methodology Use Case Analysis User Story Analysis...

Tags for this Online Resume: Services, Test, Test Cases, Extensible Markup Language (XML), HP, Microsoft Windows 7, Windows 7, Actor, Audit, CFR Part 11

Director or Manager MIS or IT - 20 Years of Experience - Near 11803

CAREER SUMMARY An information technology (IT) professional that is passionate in achieving global company objectives. A high energy diversified team player collaborating with and supporting all levels of employees and vendors. Well organized, detailed oriented, flexible and self motivated in implementing and supporting projects while aiming towards results of corporate initiatives. Key areas include: * Data Center Operation...

Tags for this Online Resume: Budget Forecast, Budgeting, Disaster Recovery, Forecast, Help Desk, Information Technology, Management, Audit, it jobs, software, agile, html, c#, sql, linux, java, javascript, c++, Hardware implementation

Life Scientist - 38 Years of Experience

Develop (Opus Bio Technologies/ QAL.LAB.) Protocol development and execution such as IOQ's assisted in coordination for field work. Prepared final reports, reviewing Kaye print out data qualifications for final reports and signing reviews for reports. Meetings with client to coordinate work schedules. Field execution Autoclaves, PLC's, Tanks lab. Equipments qualification IOQ, PQ, (Incubators, Freezers, Autoclaves, Ovens, Re...

Tags for this Online Resume: HVAC, Utilities, Documentation, High Performance Liquid Chromatography (HPLC), Audit, EDP, Inventory

Quality Coordinator - 5 Years of Experience - Near 08817

PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...

Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting

Network Engineer - 13 Years of Experience - Near 23188

Experienced with MSP applications such as Connect Wise and Kaseya providing comprehensive IT support to small and medium size businesses. * Palantir. O365 Migration Consultant, Palo Alto, CA 4/17 - 7/17 Created documentation to minimize foreseeing users' migration disruptions. Ei, Distribution list, Rooms, Transport Rules etc Worked with Power shell to create Bulk users, Distribution lists, O365 Groups, and place mailboxes ...

Tags for this Online Resume: Active Directory, Applications, Blackberry, CFR Part 11, Cisco, Cisco Switches, Database, Database Applications, Dell, Desk Top Support, Netwrok Engineer

Business Analyst

Qualifications Summary * Over Twenty years' technical writing experience in an enterprise delivery setting. Expertise with end-to-end SDLC/ITIL software development process industries I've worked in include: Electric Utilities, Financial Services, Mining, Food and Beverage, Food and Produce Distribution, Health Imaging, Manufacturing, Oil and Gas, Pharmaceutical IT, Retail and Media Relations * Develop both classroom and we...

Tags for this Online Resume: Documentation, Lightweight Directory Access Protocol, Research, Research and Development, Risk Analysis, Script, Technical Documentation, Test, Test Script, Technical Writing

Engineer

SUMMARY OF QUALIFICATIONS Experienced in diverse Engineering project and solutions for Automotive, Power Generations, Pharmaceutical /Bio-tech and Packaging /conveyor industries. Hands-on Hardware Engineering, CAD development and Design Management. Successfully led in-house process improvement, risk analysis, critical path analysis, Identify and Evaluate potential failures and TIMWOOD lean process. BS from Cleveland State U...

Tags for this Online Resume: Automation, Engineering, Documentation, Drafting, Process Improvement, BASIC Programming Language, C++ Programming Language, CAD Tools, CFR Part 11, Fabrication

Chemist

SUMMARY OF QUALIFICATION An accomplished research professional with excellent communication skills who is organized, detail oriented and a team player. Has over 21 years of experience and extensive background that includes leadership role in analytical research in many reputed pharmaceutical organizations. KEY AREA OF EXPERTISE Lead and supervised a team of scientists to execute analytical method development, method validat...

Tags for this Online Resume: DSC, Emerging Markets, High Performance Liquid Chromatography (HPLC), Spectrophotometer, Management, Engineering, Reverse Engineering, Accounting, CFR Part 11, Cost Accounting

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

Featured Profile

Clinical Data Management

Summary: Senior data scientist statistical machine learning expert * Senior Data Scientist/Applied Mathematician/Statistician: Experienced architect and developer of statistics and machine learning applications in many areas. Extensive experience with R, SAS, MATLAB, S-PLUS, S, NONMEM, BUGS, STAN, and Maple. Background in analytics for logistics, fraud, Dodd-Frank Comprehensive Capital Analysis and Review (CCAR) regulations...

Tags for this Online Resume: Architect, C# Programming Language, CFR Part 11, Data Warehouse, Hepatitis, HIV, Microsoft .Net, Microsoft Windows, Oracle PL/SQL Programming language, PDF

Business Analyst

To secure a position that utilizes my skills & experience in Business Analysis, Regulations such as GCP, FDA 21 CFRs Part11, 820, CSV and expertise in advanced communications & web-based Quality Assurance.

Tags for this Online Resume: Management, Acceptance Testing, Documentation, Test, Test Cases, Test Plan, Test Plans, User Acceptance Testing, SDLC, Business Requirements