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Online Resumes with "21CFR"
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...
Quality Assurance Specialist
Skilled and qualified QA professional able to develop, implement and train staff to meet requirements, cGMP’s, 21CFR111, ISO9000, and Food Safety elements. Experienced at all levels of the Quality Management System, including investigating, communicating and resolving customer complaints using SPC and data driven solutions to lead improvements.
Tags for this Online Resume: Quality Manager, Quality Engineer, ISO9000, Food Safety, CAPA Coordinator, Supplier Management
Application Support
Tags for this Online Resume: Robohelp, Framemaker, Word, 21 cfr part 11
21CFR111 Fluent
Job only, already had a career
Tags for this Online Resume: scientist, nutritionals
Medical Device
Positions of interest in the medical device field are: product development, biomedical service/repair management, support, quality, engineering, project engineering, reliability engineering, quality engineering. Interested in high-level single contributor or mgt level with direct reports. May include: new product launch, support services, CAPA, FMEA, project management, change order, process improvement, supplier audits, ...
Ideal Companies: Medical Device
Tags for this Online Resume: product development, CAPA, Quality, Service Repair, Technical Support, Engineering Change Order, medical device, quality audit, ISO 13485
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
Senior Scientist - M.S. Biologist, medical diagnostic industry, 20+ years experience. R&D, Manufacturing, Quality Assurance, Technical Support, and Quality Systems.
M.S. Biologist, molecular biology background, medical diagnostic industry. Experienced in R&D, Manufacturing, Quality Assurance, Technical Support, 21 CFR 820, audits, submissions and FDA communications. Proficient in technical reports, documentation, presentations, analytical instrumentation (HPLC, CE, UV-VIS), statistics (JMP, DOE, SPC, specifications), immunoassay development (ELISA, purification, conjugation), test meth...
Tags for this Online Resume: Medical Device, Quality, Auditing, molecular biology, manufacturing, regulatory, Quality/Regulatory, Biologics Manufacturing, MicroBiology/Environmental Monitorrig, Regulatory Affairs
Quality Assurance Manager-30 years experience
Lead quality Assurance activities to a 5 star quality system for compliance to 21CFR, ISO 13485
Tags for this Online Resume: quality, QA, manager, assurance, Quality Assurance, director
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.
Product Compliance and Safety Engineer
Global Product Compliance ( Regulations | Standards) Safety Engineering ( Medical | ITE) Quality Assurance ( Design Controls | Risk Management ) QMS Auditor ( 21CFR820 | 13485 | 9001 ) System Design ( Medical | ITE ) Electrical Engineering ( Medical | Safety | EMC | RF ) Manufacturing Engineering ( Medical | DFM ) Test Engineer ( Electrical | EMC )
Tags for this Online Resume: Product Compliance, Safety, QA & QMS Auditor, System Design, Electrical Engineer, Manufacturing Engineer
Quality Assurance Specialist greater Boston area
Extensive experience in Designing, Implementing and monitoring Quality Management Systems such as ISO 9000:2000, ISO 13485:2003, and 21 CFR 820.Additionally, Supervisory experience in the manufacturing and shipment of medical devices within a multi-culture, fast pace, environment. Coordinated, planned and executed activities to assist manufacturing in meeting production schedules and staying within budget. Good understandi...
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
