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Online Resumes with "fda "



Assistant Manager - 10 Years of Experience - Near 07041

Summary of qualifications: * Experience with Evaluating Reports and Creating Statistical sharing Platforms for Pharmaceutical Industry, Hematologic Oncology, Aphaeresis, Bone Marrow Transplantation and Cellular Treatment fields, Orthopedic Surgery, * Pharmaceutical, Furniture and Medical supply industries management and director experiences. * Representation and Building good relationship between industries and Associations...

Tags for this Online Resume: Statistics, Cellular, Oncology, Surgical, Trauma, Networking, Orthopedic, Orthopedics, Pharmaceutical, Wholesale

Quality Control

SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...

Tags for this Online Resume: Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits

Clinical Pharmacovigilance/Drug Safety

SUMMARY Over 35 years of cumulative global molecular research experience with an in-depth knowledge of genetic engineering, transformation, cell-culture and aseptic techniques. Well recognized in the areas of research and product development, project management and technical support in pharmaceutical and biotech industries. Ten years of experience working with United States Pharmacopeia (USP) as Expert Committee Ad Hoc Advi...

Tags for this Online Resume: Protocol, Management, Procurement, Research, Training

ERP

Experienced with FDA cGMP and related regulations and guidelines with knowledge of computer validation methodologies and principles * Expert knowledge of tools and accelerators such as Solution Manager, SAP Infopak, HP ALM (Mercury System), * Expert configuration knowledge of SAP Planning and Manufacturing (PP PP-PI REM) MM Materials Management, Quality Management QM Batch Management, Classification with cross-functional kn...

Tags for this Online Resume: Business Development, Inventory, Inventory management, Management, Procurement, Acquisitions, Application Support, Computer Aided Software Engineering, Consulting, Distribution, it jobs, software, agile

Department Manager - 20 Years of Experience - Near 45302

SUMMARY Manager with extensive experience in lean manufacturing, and Six Sigma implementation in multiple production environments. Change agent who strives to bring about breakthrough improvements in a very effective time. Adept at recognizing root cause problems solving and instituting preventive actions while developing high performing work teams. EXPERTISE * Team Leadership Manufacturing Optimization Lean & Six Sigma Str...

Tags for this Online Resume: Training, Capital Equipment, Leadership, Manufacturing, Packaging, PET, Plastics

Quality Specialist – two years of experience – Qualification of raw materials - Quality Assurance – Compliance – Change controls- FDA requirements – SOP’s – cGMP-familiar with CAPA

In my two years of experience at Johnson & Johnson, I have gained vast knowledge about different areas : Quality assurance,Complaince, Procurement and Analytical but my goal is to excel in the field of Compliance/Quality Assurance with high level of persistence

Tags for this Online Resume: Compliance, Quality Assurance, Change controls, Leadership, SOP, Computer

Research Nurse- 7 years in Research; Management

I would like to work for a company that is reliable, results driven, proven accomplishments, as evidenced by return customers in the research industry. I want to be a part of FDA approved drugs/devices, etc.

Tags for this Online Resume: Registered Nurse, Recruiter for subjects, Protocol Specific, Clinical Research Nurse, Coordinator, Assertive

Quality Assurance Specialist - 20 Years of Experience

Qualification Summary * Strong and diverse professional experience in Quality field Quality Engineering, Supervision, Process Engineering, and Project Management. * Expertise in the application of Statistical Analysis, Advanced Quality Tools, Statistical Process Control (SPC), * Total Quality Management Continuous Improvement. * Excellent Team management/Facilitation skills, handle multiple tasks and fast paced environment....

Tags for this Online Resume: Data Analysis, Medical, Complaints, Quality, Risk Analysis

Clinical Research - 5 Years of Experience - Near 19128

SUMMARY * Project coordination, document management and coordination experience in a clinical health environment in pharmaceutical industry. Worked for Spark Therapeutics, Baxter, Execupharm, United BioSource (an Express script company) and Liquent (a Parexel Company) * 3 + years of experience in Regulatory Affairs supporting the compilation of regulatory submission and assisting with the publication those submissions using...

Tags for this Online Resume: Documentation, Microsoft Excel, Microsoft Office, Microsoft Outlook, CVS, Distribution, Document Management, Documentum, Documentum (Wkflow Sw), Financial

Chemist - 20 Years of Experience - Near 02467

PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities

Chemist - 20 Years of Experience - Near 78720

Career Summary Quality control and method development for nutrition products. * Project management for government /military funded projects as well as collaboration with sporting goods and chemical industries for prototype product development and marketing technical support. Multi-tasks management, coordinate cross-functional activities between groups and related sub-contractors within project timeline and budgets. * Proto-...

Tags for this Online Resume: Resource Scheduling, Scheduling, Test, Troubleshooting, Budgeting, Clinical Research, Marketing Management, Product Launch, Project Management, Project Manager, pharmaceutical, Sr. Analytical Chemist

Industrial Engineer - 15 Years of Experience - Near 06422

SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...

Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,