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Online Resumes with "FDA"



Document Control, Engineer Technician, Minneapolis

Continue to help companies improve their documentation system to FDA standards, or to work with engineers and help with their documentation needs. With 15 years manufacturing background, and 9 years documentation background I can step into positions and assist where needed.

Featured Profile

Regulatory Affairs Subject Matter Expert

Seeking a regulatory affairs or clinical laboratory position with a team of professionals whose mission is to provide excellent research or patient care.

Ideal Companies: Device manufacturers; Emergency treatment facilities; Research and Development

Tags for this Online Resume: Research and development, Medical Technology, PCR, Clinical trials, Emergency Medical Technician, Biological Safety Suite, Research, Strategic Initiatives, Business Plan, Medical

Featured Profile

Registered Nurse

30 yrs Nursing experience, seeking a part-time Nursing position

Aircraft Rigging Assembler

Tags for this Online Resume: Medical Devices, ISO 13485 AS9100 ISO 9001, FDA 820 510(k), Quality Systems Auditor, Quality Systems Author

Results Driven Leader

I am motivated by change and process improvement initiatives. I thrive in a fast paced environment. Motivating others and following through on projects and plans are my forte.

Ideal Companies: Baxter, Astellas, Takeda, Eli Lilly

Tags for this Online Resume: change management, manufacturing, documentation, cGMP, FDA

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

"Clinical Research Nurse" "Drug Safety Specialist"

Career Summary Experienced professional nurse with planning and organizational skills of project activities to support investigators in the preparation and conduct of research protocols to ensure compliance in accordance to FDA, GCP and ICH requirements.

Plant Manager, NJ

To attain a position in various realms of management, production, R&D

Tags for this Online Resume: OSHA, GMP, SEMI, FDA

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

Featured Profile

Quality Assurance Manager

I would like to pursue a Quality Assurance manager position utilizing my knowledge and experience in the Biotechnology and Pharmaceutical industry and develop or enhance existing Quality Systems. The ideal position would provide the opportunity for me to use my people skills, problem solving and creativity to meet both internal and external customer needs.

Tags for this Online Resume: quality, technical writing, compliance, cGMP, Process consultant

Clinical Regulatory Affairs

Tags for this Online Resume: Regulatory Affairs Associate, Technical Documentation, Laboratory, Research, CMC, eCTD, Annual Reports, Method Valdation, Review & Documentation, FDA Deficiencies

Operations / process Excellence / Industrial Engineering Executive

Stability, business growth, advancement opportunities, opportunity to be part of a team and develop strong buisness relationships, opportunity to favorably impact the bottom line.

Ideal Companies: Consumer Goods, Luxury Goods, Food & Beverage, manufacturing, distribution,

Tags for this Online Resume: Cost Improvement, Process Excellence, Lean Manufacturing, Six Sigma Black Belt, Operations Excellence, Value Engineering, Plant Management, Supply Chain, ERP/WMS Expertise, Project Management