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Online Resumes with "cfr"
Clinical Research - 6 Years of Experience - Near 92649
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine
Tags for this Online Resume: Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets
Quality & compliance professional with 24 yrs of experience
With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...
Tags for this Online Resume: Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809
Validation Consultant-18 years experience in cGMP regulated environment-Dallas, Georgia
Technically accomplished, results oriented professional with 17 years CFR Part 11and GAMP 5, Part 58, Parts 210 & 211, Part 600, 601,610, Part 1270, 1271and Part 820 cGMP regulated environment with 10 years working experience writing, developing and executing validation protocols, managing calibration programs, maintaining and upgrading automated systems in a cGMP environment. Creative Metrologist/Chemist/Biologist and (IQ,...
Quality Engineer - 14 Years of Experience - Near 91016
Over14 years of in-depth experience in the pharmaceutical industry. Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation
Property Site Manager - 20 Years of Experience - Near 22312
COVER LETTER Timothy Hugee 5575 Vincent Gate Terrace, Apt 1325 Alexandria, VA 22312 Phone: 703-655-0714 Email: timhugee@gmail.com Professional experience Experience in maintenance management, maintain budgets and proven abilities in leadership skill, motivating employees towards a common mission, effective organizational skills, and the ability to educate others to assist in achieving overall goals. Experie...
Tags for this Online Resume: HVAC Tech, Stationary Engineer, Lead Building Engineer, Chief Engineer, Maintenance Director
Quality Manager - 6 Years of Experience - Near 79702
Motivated, personable business professional with diverse experience and expertise. Talent for quickly mastering new technologies. Diplomatic and tactful with professionals and non-professionals at all levels. Accustomed to handling sensitive, confidential records. Flexible and versatile – able to maintain a sense of humor under pressure. Poised and competent with demonstrated ability to train new hires as well as seasoned ...
Ideal Companies: Baker Hughes, Conoco Phillips, Shell, Marathon Oil,
Federal Government - 3 Years of Experience - Near 07753
Highly motivated individual with a proactive approach to accomplish any mission. Detailed oriented, team player, able to multitask in a fast working environment. Emergency Management professional with a history in Community Relations, Planning, and Hazard Mitigation sections. Skilled in implementing project management principles. Excellent problem solving and analytical skills experiences in various situations while facing ...
Tags for this Online Resume: 44 CFR, MBI, Project Specialist, NEMIS system, e-Quip, FEMA
Technologist, primarily in heavily regulated pharmaceutical and financial industries
Maximizing investments in technology, a proven leader that leverages partnerships between business areas and technologist resulting in value added environments.
Ideal Companies: Financial, Healthcare, Technology
Medical Scientist - 14 Years of Experience - Near 30269
I'm a Bilingual, Army –Trained Medical Professional with pharmaceutical experience to include GxP, quality control immunoassay testing, environmental monitoring, laboratory investigations, and exception reporting. My Army Service includes 10 years experience in Clinical and Research applications of microbiology, phlebotomy, hematology, resource management, safety, risk assessment and mitigation, process improvement and emp...
Tags for this Online Resume: GMP, GDP, GLP, MP, Quality Conol , Pharmaceutical, 21 CFR 211, Non Conformance reporting, CAPA, Quality Control Associate, Root Cause Investigations, Scientist, Microbiology, Environmental Monitoring, Assessments, Audit, ELISA, Quality, Quality Assurance, Quality Control, Research, Test
Quality Manager - 20 Years of Experience - Near 60096
Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...
Tags for this Online Resume: CAPA, FDA, ISO, Complaints, Auditor
Project Manager - 10 Years of Experience - Near 07901
Ms. Marilynn Goldsmith is a PMI certified Project Manager. Her experience includes projects in integrated oil, insurance, and pharmaceutical sectors. She has been responsible for the project schedule, categorization and management of issues, risks, change and quality management of project deliverables including managing 21 CFR Part 11 Validation and the associated deliverables.
Tags for this Online Resume: SDLC, Offshore Teams, MS Office, Deliverable , Validation, Quality, Team Mgmt, Issue/Risk, Management, Oracle, Database, Documentation, Oracle Database, PWC, Requirements Definition, SEC
Senior Process Validation Lead
Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.
