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Online Resumes with "fda regulations"



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

Featured Profile

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

Featured Profile

Clinical Research Associate

SUMMARY OF QUALIFICATIONS • Foreign graduate Medical Doctor and licensed RN with more than 22 years of clinical and research experience. US citizen. Fluent in English, Russian and Romanian • Extensive training in Good Clinical Practices, ICH Guidelines, SOPs through various Sponsors • In depth therapeutic and protocol knowledge as per Sponsor’s assignment. Excellent organizational and problem-solving skills.

Ideal Companies: Biotech companies

Tags for this Online Resume: research associate, biotech, CRA, Las Vegas, pharmaceutical, health

Analytical chemist

Extensive expertise in quality control, quality compliance, method validation functions, and in performing qualitative and quantitative analyses on pharmaceutical products. Proven record to work under tight dead lines and deliver quality work on time. Goal oriented team player with technical capability to manage multiple functions simultaneously. Proven analytical thinker in solving problems by identifying cause and char...

Tags for this Online Resume: Method Validation, Compliance, QA, Quality Control

Supply Cahin Management/Purchasing

MIKE ANDERSEN, C.P.M 7746 105th Avenue (262) 697-1813 Pleasant Prairie, WI 53158 mike_a53158@yahoo.com CAREER PERSPECTIVE An accomplished C.P.M. and Global “Supply Chain” control manager having the ability to negotiate cost as well as analyze quality improvement projects; partnering with local to off shore sources; using FAR, FDA and ISO polices and procedures. I continue to utilize my extensive procurement backgr...

Tags for this Online Resume: Purchasing, Materials Management, Lean Six Sigma, C.P.M., Oracle, IFS

Program Manager

Highly motivated results-oriented Business Professional with 15+ plus years of experience with a proven track record of success in; program management, inventory management, new-product introduction, contract manufacturing and logistics. Adept at analysis and business re-engineering, cycle time reduction can quickly solve business challenges. Well organized with excellent follow-through and follow up skills. Core compete...

Ideal Companies: Cisco, Network Appliance, Juniper Networks

Tags for this Online Resume: Account Management, Demand Planning, Program Management, NPI New Product Introduction, Supply Chain, Master Scheduling, Logistics, Materials Management, Engineering Change Process, FDA/GMP, MRP, Re-engineering Processs

Regulatory Specialist II, Tampa, Florida

I have over 10 years of experience working as a Regulatory Specialist. I love all aspects of clinical research. I enjoy reading a protocol and learn how that particular study may help certain group of people. My goal is to find a position where I be responsible for providing guidance to study personnel regarding regulatory and IRB issues, Good Clinical Practices, and FDA Regulations. To be in charge with maintaining and r...

Tags for this Online Resume: Clinical Research, Regulatory Specialist II, Pharmaceutical Clinical Trials, CRA

Featured Profile

Registered Nurse - Drug Safety Associate,Coder, Product Surveillance/Product Safety

I am seeking for a stable and well established company that is growing. Also,what I am looking for in a new job is for employers that care about their employees and acknowleges them for their good hard work. I would also hope that good training is provided so that the individual such as myself can be productive for the company and contribute towards it's success rate. I would also hope that it was a warm welcoming environm...

Ideal Companies: Cephalon Pharmaceutical, Teva Pharmaceutical, Azur Pharmaceutical, GlaxoSmithKline, United BioSource

Tags for this Online Resume: Registered Nurse, Drug Safety Associate, Coder, Safety Surveillance, Adverse Event Coordinator

Senior Chemist - 9 years experience; Teacher - 2 years experience

Greetings, I hope this letter has found you in the middle of a very joyful work week. My name is Tyson. I have recently relocated to Little Rock AR and I am looking to find a suitable career vacancy. I have several years’ experience verifying and producing detailed reports for chemical analysis across a few different industries. My professional career has focused on chemical analysis and education. My laboratory backg...

Tags for this Online Resume: Teacher, Message Delivery, Communication, Analyst, Detailed, Coordinate, Validation, Analytical, Team Player

machine operator / manufacturing technician operator hayward ca.

manufacturing technician in pharmaceutical company that complies cGMP,SOP and FDA regulations.

Tags for this Online Resume: machine operator, manufacturing tech.operator, chemical cleaning operator, mixing ingredient compound , batch record review and interpretation

Clinical Trial Professional

Detailed oriented Clinical Research Professional with medical education background and several publications. Extensive experience working on complex clinical trials in a critical care, cardiology and podiatry environment. Solid knowledge of GCP/ICH guidelines and FDA regulations. Well versed in medical terminology and medical procedures. Possess excellent communication and presentation skills.

Tags for this Online Resume: Clinical Research , Clinical Research Associate, Drug Safety Associate, Clinical Trial Associate, Research Scientist