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Online Resumes with "cfr"
Documentation Associaye 17 years Experience in Pharmaceutical industry
CAREER SUMMARY Quality Assurance Professional with experience in pharmaceutical manufacturing enforcing quality standards in a manufacturing unit. Skilled at studying industry and consumer requirements, running tests, writing quality assurance procedures, preparing quality reports, and assigning quality assurance tasks to employees. Proficient interacting with various departments including Supply Chain, Production, MS&T, Va...
Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Supply Chain, Change Control, Compliance, Corrective Actions, Documentation, Folder, Forecast, Management
Power Generating Plant Operator
Summary Maintenance Foreman with KCP&L at the LaCygne Generating Station. My responsibility is to plan maintenance, supervise maintenance department, commissioning and startup of the new AQCS (backend) here at LaCygne. I am also a board member for KCPL Maintenance Apprentice Program. My previous position at Unilever Foods was the Maintenance Planner / Foreman for the maintenance department. I've managed the work in the main...
Tags for this Online Resume: Heat Exchangers, HP, Instrumentation, Layout, Low Voltage, Manufacturing, Packer, Schematics, Troubleshooting, Valves
Distribution manager - 20 Years of Experience - Near 77049
COVER LETTER: Dear Hiring Manager: I am contacting you in regards to the Chemical Warehouse Manager position located in Friendswood. I am very interested in this position. My relevant qualifications include 27 years in the Warehouse and Distribution field. I am Hazmat Certified to include DOT and Maritime 49 CFR by Cargo Training Intl. Also of note is my current position as the Warehouse Manager for The Rectorseal Corp. for...
Tags for this Online Resume: Audit, Distribution, Excellent track record, Transportation
Medical Transcriptionist
Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...
Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control
Engineer
Summary Duke Energy qualifications include 10 CFR 50.59 Applicability and Screening, QR reviewer, TXS HW and SW reviewer, IV&V document reviewer and Duke drawing reviewer. NPPD Cooper qualifications included SGI and Critical Group. SCE SONGS qualifications include NECPs, 50.59 screening and evaluations, SGI and Critical Group. Working knowledge of a variety of Microsoft software packages including Word, Excel, Access, and P...
Tags for this Online Resume: Security, Cyber, Cyber Security, Assessments, Call Center, Dec, Engineering, Independent Verification and Validation, Microsoft, Microsoft Access
Quality Assurance Engineer - QSR/ISO13485 - Validation
To work for a Medical Device company where my experience and skills in Quality Assurance and Validation can be put to good use. What I value most in my career: 1) Personal confidence that I can do the job/task. 2) Upper management confidence that I can do the job/task. 3) Satisfaction that the career/job I’m doing is worthwhile and benefits others. 4) People important in my life recognize value in what I do and that I ...
Ideal Companies: Roche, Johnson&Johnson, Genentech, Eli Lilly
Tags for this Online Resume: Quality Assurance, Medical Device, Validation, ISO 13485 Auditor, TrackWise, Validation - Process, Equipment, ISO 13485 Compliance Auditor, Risk Management, ISO, ISO 9001
Director of Quality - 24 Years of Experience - Near 11801
Professional Summary Highly effective professional offering 30 years of US global quality leadership experience developing strategies, improvement action plan and solutions. Dedicated leader to bring organizations together, focusing on hi performance culture leading to improvement and efficiency. Built fully engaged team that is motivated to achieve metrics and deliver ROI. Lead and empowered cross functional teams to impro...
Ideal Companies: end of the year 449.00 + 4 months of our service. resume rewtire and cover letter.
Tags for this Online Resume: TQM (Total Quality Management), Manufacturing, Assessments, Audit, Quality, Quality Management System, HACCP, Continuous Improvement, PCQI, Supplier site and internal audits, USDA, FDA, ISO 9001, SQF, BRC, ISO 22000, ERP, OOS, Investigation, CAPA, NCR
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
Quality Engineer
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: Packaging, Manufacturing, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Quality Control, Training
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
Project Manager - 20 Years of Experience - Near 60124
Skills Summary A Senior Software Professional who has exceptional project management, client relationship and leadership skills with a proven track record of managing multiple projects with multiple stakeholders and multi-disciplinary teams delivering projects on time, on budget and to the client's satisfaction. * A certified PMP having 20+ years of Software Engineering experience that includes: * Project Management and Sta...
Tags for this Online Resume: Project Management, Project Manager, Management, Oncology, ISO, Pharmaceutical, CFR Part 11, Documentation, Change Management, Insurance