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Online Resumes with "21CFR"
Senior Business Systems Analyst/IT Project Manager - 7+ Years of Experience - Chicago IL
Strategic and innovative Senior Business Systems Analyst/IT Project Manager with over 7+ years� experience leading large scale IT projects. Highly accomplished and forward-thinking, with diverse expertise in IT systems and business systems analysis. Talented senior system analyst and senior business systems analyst with broad IT experience across multiple sectors. Create, design and implement efficient, consistent and strea...
Ideal Companies: Baxter, Takeda, JP Morgan Chase, Citibank, HSBC, Allstate, Bank of America, Standard Chartered, State Farm, Johnson & Johnson, Procter & Gamble
Tags for this Online Resume: Business Requirements to System Design, Laboratory/QA Systems like LIMS, Empower 3, ELN, Atlas, SDMS NuGenesis Configuration/testing, Regulatory Compliance for FDA, EU Annex 11, 21CFR Part11 Compliance, ERP SAP-QM, SDLC/Waterfall/Agile Development Methodologies, Project Management, Custom Software Development, Systems Engineering, System Risk Mitigations/Integrations, Enterprise wide implementation, ROI Analysis, Costing , UAT, System Integration Testing, Performance Testing, Regression testing, Acceptance Testing, Validation Testing Scripting and documentation. GXP, GMP, GLP, GCP, Lean Six Sigma Green Belt expertise, C, Oracle 10g/11g, SQL Server, PL/SQL Stored Procedures, Costing, Project Scheduling, Cross-Functional Supervision, Team Building, Client Relations Presentations, Business/IT Planning, Vendor Management, UML Designing, MS Project, Gantt Chart, MS Office, Rational Rose, URS, FRS, SDD, Installation, Traceability Matrix, BI, Cognos, QlikView, Infomaker Report, MS Test Manager, Sharepoint, Business Operation Excellence, Process Improvement Excellence
Technical Writer
Thirteen years experience in multiple industries at all organizational levels coordinating technical documentation creation and editing while interfacing with Subject Matter Experts, on-site engineers and technicians, and business partners. Currently seeking challenging opportunity.
Tags for this Online Resume: MS Office, Adobe Framemaker, MS Project, Factory Automation, Laboratory, IQ, OQ, PQ, Validation, Commissioning
Clinical Quality Assurance - 17 Years of Experience - Near 27713
QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...
Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance
Production Manager - 18 Years of Experience - Near 02725
SUMMARY Eighteen years experience in Manufacturing or Manufacturing support, including over ten years of supervisory experience. Proven ability to drive production against aggressive schedules while rigorously maintaining safety, quality, and regulatory standards. Expertise in training, documentation, and technical transfer functions. Familiarity with Lean Manufacturing and continuous improvement initiatives. Extensive expe...
Tags for this Online Resume: Documentation, Good Manufacturing Practices, Support, Compliance, Housekeeping, Management, Utilities, Evaluate, Kaizen, Lean Manufacturing
Clinical In-house Monitoring - 6 Years of Experience - Near 07621
SUMMARY OF QUALIFICATIONS Pharmaceutical professional with 5+ years of clinical research experience in management and monitoring. Seeking new and exciting opportunities in new therapeutic areas to expand my expertise. Known for building strong relationships with clients and partnering with management teams to ensure quality services, compliance and efficiency. Manage Clinical Research, third party vendors, and clinical inst...
Tags for this Online Resume: Fraud, ICD-9, Insurance, Medical, Query, Management, Good Clinical Practices, ICH, Documentation, Clinical Research
Electromechanical Equipment Assembler - 1 Years of Experience
SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.
Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control
Developer - 7 Years of Experience
PROFESSIONAL SUMMARY * Over 9 years of Clinical SAS programming experience in a Pharmaceutical industry involving different Phases (I, II & III) of clinical trials. * Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries and Graphs/Figures (TLFs) for the Integrated Summary of Safety (ISS) and Integ...
Tags for this Online Resume: Microsoft Windows, SAS, Structured Query Language, Unix, Microsoft Windows 7, Windows 7, PDF, Proc, Extensible Markup Language (XML), Microsoft Excel
Director of Quality - 20 Years of Experience - Near 08810
Summary: Engineering professional with over 30 years of experience in developing, implementing, and managing Quality and Manufacturing management systems. Management experience includes working in small companies to global leaders in metal and plastic industries in diverse manufacturing environments. Working knowledge of ISO 9001, QS 9000, SQF, HACCP, cGMP, FDA (2ICFRPart 110,111,210,211), APQP (Advanced Product Quality Pla...
Tags for this Online Resume: ISO, Manufacturing, Process Control, Quality, Quality Assurance, Audit, Internal audit, ISO 9001, Management, Plastics, SQF, Food Safety, Risk Management, Quality System Implementation, Metal Fabrication, ANSI, ASTM and Mil Standards, FDA, 21 CFR 110,210,210,211, manufacturing, "project management", reliability, production
Engineer - 19 Years of Experience - Near 33184
Tags for this Online Resume: Audit, Product Development, Risk Analysis, Software, Software Development, Support, Technical Support, Test, Documentation, Quality, Validation, Verification, Human FActor, CAPA, ISO 14971:2012, GMP, 21CFR Part 11, SPC, Post Launch Risk Assesment
Clinical Research - 10 Years of Experience - Near 18901
Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...
Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development
Architect - 11 Years of Experience - Near 08817
PROFESSIONAL SUMMARY * Experienced Selenium Automation Testing. * Good experience in Web UI automation testing with Selenium Web Driver, Java, Junit, TestNG frame works. * Proven experience in using Java and CSharp for Automation * Experienced in setup Project Setup in Eclipse * Experienced in suggest and creating new Framework from scratch or can adopt existing frameworks as well. * Experienced in working on Data Driven fr...
Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Integrate, Test, Test Plan, Java Programming Language, Javascript, Selenium, Sharepoint Technologies, Test Script
Business Analyst - 7 Years of Experience - Near 08817
Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing ...
Tags for this Online Resume: Business Analysis, Business Analyst, Information Technology, Acceptance Testing, Active Server Pages, Adobe, Adobe Acrobat, Agile, ANSI, Ansi (Am Natl Stds Inst), PMP certified, VISIO,MS Project
