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Online Resumes with "FDA Regulation"
Clinical Research - 3 Years of Experience - Near 02478
Summary: MS in Clinical Investigation with 3+ years of experience as Clinical research assistant cum coordinator seeking a preferably full time position in Clinical Research fields as Clinical Trial Associate / Project Management. Offering combination of strong background in biological sciences (specialization in Oncology, Molecular biology) as well as deep understanding and knowledge of ICH-GCP & FDA regulations. Demonstra...
Tags for this Online Resume: Clinical Research, Documentation, Research, Advertising, Audit, Budgetary, Data Entry, Data Management, Filing, Gastroenterology, Recruting, IRB admministration, regulatory, phase ii, clinical trials, ICH-E6 GCP and GLP, HIPAA compliance
Facilities Manager
AREAS OF EXPERTISE: Wide range of expertise in project engineering, construction management, third party facilities management, high rise real estate, maintenance management, plant operations, engineering, design and project management of ventures ranging from $50,000 to $760 million dollars. Facilities Engineering and Design Consultants (F.E.D.C.) Facility Management, Project Engineering, Design & Property Management Compa...
Tags for this Online Resume: Autocad, Autocad 3D, Autodesk AutoCAD, Budgeting, Cancer, Cobra, Cogeneration, Construction, Consumer Products, epa
Customer Service Manager - 7 Years of Experience - Near 92887
Summary: Utilize my skills, knowledge and experience for your company whereby my team leadership and business expertise can enhance profitability as well as improve the outcome of your growth-orientated business. Accomplishments: * Followed Quality System Regulations & Requirements for Regulatory Purposes (FDA regulated, ISO & OSHA standards, SOP's). * Created Standard Operating Procedures for warehousing, logistics and inv...
Tags for this Online Resume: Leadership, Accounts Receivable, customer service, customer service representative, Accounts payable, Medical industry, Warehouse Manager, SOP's and Quality Documentation, Account management, Staff accountant, Inventory conrol, Purchasing, Sales operations representative, Order entry, Invoicing
Scientist - 5 Years of Experience - Near 94706
SUMMARY: 1. Multidisciplinary background in biochemistry, biophysics, chemistry and material science: three-year UCSF School of Dentistry postdoctoral training in biochemistry / biophysics and five-year Ph.D. research training in chemistry (biointerface design and analysis). 2. Successfully led or involved projects about biomolecular expression and analysis. 3. Proven ability to lead and work with cross-functional teams fro...
Tags for this Online Resume: Research, Chemistry, Western blot, Distribution, ELISA, High Performance Liquid Chromatography (HPLC), Imaging, Microsoft Office, Pharmaceutical, Science
Industrial Qualification Engineer - 20 Years of Experience - Near 35758
Accomplish engineering manager with extensive qualification/validation experience in the FDA regulated industries including electronic batch records. Skilled in process development optimization and design of experiments. Extensive hands on operating knowledge from design basis through commercial manufacturing in the solid dosage parenteral biotechnology bulk chemical and medical devices fields. Career experience in US Mexic...
Tags for this Online Resume: Packaging, ISO, Utilities, Complaints, Management, Compliance, Manufacturing, Assessments, Endoscopy, Audit, hvac controls, lonworks, test
Project Manager - 20 Years of Experience - Near 60015
SUMMARY * Performance-driven, business-oriented technology professional with a record of success delivering IT solutions for core business. * PMP certified project manager experienced in FDA-regulated, information governance, data warehouse, and business intelligence systems. * Expertise in various types of methodologies such as Waterfall, Agile, Iterative, and hybrid. * Led ERP, DW/BI, GRC, and web-based systems across pha...
Tags for this Online Resume: Oracle, Business Intelligence, SAP, Supply Chain, Systems Analyst, Enterprise Requirements Planning, Legacy, Web, Web Portal, Web Technologies
Engineer - 3 Years of Experience - Near 91367
A proactive, results-oriented engineering and validation professional with experience in cGMP/FDA regulated manufacturing with educational background in electrical engineering, seeking a challenging position that offers professional growth and development. Key strengths include technical writing, process development and project planning. Certificated with a Green Belt for Six Sigma, organized, team oriented, focused with th...
Tags for this Online Resume: Engineering, Manufacturing, Market Research, Process Engineering, Quality, Quality Assurance, Quality Control, Research, Test, Test Plan
Production Manager - 157Years of Experience - Near 08723
SUMMARY * B.S. Biochemistry + M.B.A. Pharmaceutical Management with over 17 years of pharmaceutical industry experience * 12 Years of Parenteral Manufacturing experience. Member of PDA. Attended Courses at University Tennessee * 13 years of production experience in an FDA regulated environment such as Biopharma, OTC, medical devices in clinical, commercial drugs, consumer products, and nutraceuticals. * 11 years of producti...
Tags for this Online Resume: Forecasting, Medical, Project Management, Project Manager, Scheduling, 5S, Engineering, Kaizen, Outsourcing, SAP, production, manufacturing, reliability, "project management", Clinical drug supply, Packaging and labeling, GMP andGCP, SOP, 21CFR11
Scientist - 5 Years of Experience - Near 08830
PROFESSIONAL SUMMARY * Experience in design and development of variety of dosage form semi-solid (cream, lotion, gel, ointment), liquid (solution, suspension) and nasal spray. * Experienced in preformulation, characterization and formulation optimization using solubility, skin diffusion, in-vitro diffusion, viscosity, yield stress, pH etc. * Designed Quality Target Product Profile (QTPP) and identified Quality Attributes (Q...
Tags for this Online Resume: Manufacturing, Quality of Service, Distribution, SEMI, Assessments, Centrifuge, Development Activities, DSC, Good Laboratory Practices, High Performance Liquid Chromatography (HPLC), pharmaceutical, research
General - 13 Years of Experience - Near 10701
Summary of Qualifications Enthusiastic, self-starter with the ability to present products/ideas persuasively and build rapport. Flexible, multi-tasker with a strong work ethic and ethics and character of the highest caliber. Creative, attentive to the completion of precise tasks and projects. Enjoys taking initiative beyond stated job and is sensitive to needs of others. Qualified professional providing expertise in the lab...
Tags for this Online Resume: Technical Writer, Quality Assurance, Regulatory Affairs, Research, Compliance, Manufacturing, Quality, Quality Control, Documentation, Reliability, Research and Development, Document Control, HIV
Quality Assurance Specialist - 14 Years of Experience - Near 07871
SUMMARY Manager and Project Coordinator of Scientific Systems with over 25 years of experience in the Pharmaceutical and Scientific field. Well versed in FDA Regulations for scientific data collection validation. Proven ability to work in coordination with Clients and Project Teams to conform to FDA Regulations. Ability to meet deadlines, working independently or as a team member. Expertise includes: * Instem Centrus Suite ...
Tags for this Online Resume: Pathology, Toxicology, CVS, Pre-clinical, Validation, GLP, Legacy, Project Leader
Clinical Research - 3 Years of Experience - Near 60626
Healthcare professional with training and experience in clinical research monitoring seeking a Clinical Research position to coordinate, monitor and manage clinical trials while safeguarding the rights and welfare of clinical trial patients by complying with the ICH-GCP guidelines, FDA regulations, Study
Tags for this Online Resume: Assessments, Clinical Research, Forth Programming Language, Good Clinical Practices, Management, Pharmaceutical, Research, Scheduling, VITAL SIGNS, Audit
