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Online Resumes with "Method transfer"
Department Manager - 20 Years of Experience - Near 92128
Areas of Expertise * Business Process Improvement * Environmental Monitoring * Inventory Control & Management * Production Planning & Scheduling * Strategic Planning & Implementation * Process Design & Validation * GMP and ISO 13485 Compliance Recruited to establish Production Reva Medical San Diego, CA Established and directed formal operations functions supporting production of pre-clinical and clinical supplies collabore...
Tags for this Online Resume: Automation, Hazardous Waste, Instrumentation, Integrate, Metrics, Order Processing, Process Improvement, Production Metrics, Management, Good Manufacturing Practices
Chemist - 15 Years of Experience - Near 92881
Experienced with trouble shooting issues in chromatography and other testing procedures resulting in effective and high quality test methods * Maintained daily, weekly, and quarterly checks of instrumentation such as stability chambers and HPLC systems as part of team responsibilities, reducing the need for a separate metrology group Scientist II (Laboratory Technical Services) 2011 Performed remediation activities for exis...
Tags for this Online Resume: Filing, Forth Programming Language, Quality Assurance, Regulatory Affairs, Test, High Performance Liquid Chromatography (HPLC), Instrumentation, Quality, Quality Control, Compliance, pharmaceutical, sop, change control, method validation, cleaning validation, hplc, fda, raw material, in-process testing, finished product, solid dose, research and development, method transfer, protocol, report
Camera Operator
Summary º Skilled professional with many years of knowledge and expertise in Quality Control and Analytical Development arena with a demonstrated record of implementing and maintaining quality systems º Extensive experience in analytical method development, method validation and method transfer for APIs, Solid / Liquid Oral Dosage Forms, and Injectables º More than six years of experience at Manager/Supervisory level º Well...
Tags for this Online Resume: Audit, Research and Development, Quality, Quality Assurance, Quality Control, Test, Corrective Actions, Utilities, Services, Troubleshooting
Chemist
Summary * Experienced Quality Assurance scientist in the pharmaceutical and biotechnology industry working for over 17 years in a cGMP and GLP regulated environment. * Lead efforts in the business analysis for the group's business continuity program and the implementation of the Laboratory Information Management Systems (LIMS). * Knowledgeable in Project Management methodologies like 5S, LEAN and Six Sigma. * Skilled in ana...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Microsoft, Microsoft DOS, Microsoft Windows, Applications, Benefits, Business Analysis, Business Analyst, Documentation, Information Technology, pharmaceutical, sap
QA/QC Manager - 5+ Years of Experience. Worked in Biotechnology, Pharmceutical, Cosmetic and Food Industry for 18+ Year - Near 02919
Professional Summary: Quality Control Manager with 10+ years of experience working in pharmaceutical, biotech, cosmetic and food industry recent experience has been in management roles with concentration on regulatory compliance and project management additional skills include chemistry and microbiology analysis, with strong technical background, effective communication and interpersonal skills, and ability to lead successf...
Tags for this Online Resume: Deviation, Stability, LIMS, HPLC, Wet Chemistry, Raw material, Technical Operation Training and development, Change Control, CAPA, Investigation, Learning Management System, Master Control, SABA, SAP, FDA, USDA, Regulatory Compliance, FDA Audit, Third Party Audit, USDA Audit, Microbiology, Method Transfer, Validation, Bioassay, Elisa
Chemist - 8 Years of Experience - Near 08855
SUMMARY: * Over 16yrs pharmaceutical experience in Quality Control, Stability and R&D, Drug development & approval, sterile injectable pharmaceutical manufacturing, solid dosage manufacturing, aseptic techniques, and clinical packaging/ labeling for top pharmaceutical companies. * Solid background in Instrumental Analysis and GMP compliance. Expertise in hands-on use of instrumentation such ICP, GC/MS, HPLC, LC/MS, UV, and ...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Research, SEC, Securities and Exchange Commission (SEC), Support, Instrumentation, Audit, Good Laboratory Practices, Good Manufacturing Practices, oncology, phase, protocol, pharmaceutical, clinical
Chemist - 20 Years of Experience - Near 00977
Summary of Qualifications Highly qualified licensed chemist with experience in Oral Solid Dosage, Parenterals Manufacturing in Quality Control Laboratory, Quality Assurance, Quality System, Quality Operations Technology Transfer and Process Scientist in Technical Services areas. Solid background in analytical methods development and process validation, analytical method transfers and cleaning validation activities. Strong k...
Tags for this Online Resume: Quality, Quality Assurance, Chemistry, Configure, Protocol, SAP, Script, Test, Puerto Rico, Quality system, Quality assurance, Labware, Lims, Empower, Quality Control
Quality Coordinator - 5 Years of Experience - Near 08817
PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...
Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Chemist - 20 Years of Experience - Near 94602
Tags for this Online Resume: Compliance, Management, Protocol, CMOS, Troubleshooting, Assessments, Evaluate, Manufacturing, OTC, Quality
Life Scientist - 6 Years of Experience - Near 46530
Over 12 years of lab experience with expertise in summarizing complex technical information into a simple form and communicating it to a diverse range of audience resulting in 6 national and international meetings, 1 peer-reviewed publication and 9 media coverage. * Self-motivated individual with easy integration in a multicultural environment with proven ability to complete projects, leading to the initiation of method tr...
Tags for this Online Resume: Research, Microbiology, Test, Quality, Quality Assurance, Quality Control, Documentation, Information Technology, Integrate, Team Player
Chemist
Tags for this Online Resume: Commercial Production, Distribution, Documentation, High Performance Liquid Chromatography (HPLC), Instrumentation, Inventory, Manufacturing, Pharmaceutical, Process Improvements, Quality
