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Online Resumes with "fda "
Quality Coordinator
Provided * Provided coverage for 2 facilities and investigator research assistance in 2 locations * Maintained Rodent, Non-Human Primate, Beagle, Rabbit, and Hound Colonies. * Reviewed GLP documentation for up-coming FDA inspections * Reviewing protocols and assisted investigators in Toxicology and Metabolism Groups emergency coverage for 2 facilities and investigator research assistance on 2
Tags for this Online Resume: Surgical, Inventory, CT, Inventory Control, PET, Spreadsheet, Toxicology, Welding, Documentation, HIV
Director of Quality
CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...
Tags for this Online Resume: Process Control, ISO, Management, SPC, Black belt, Layout, Policies and Procedures, Project Management, Project Manager, Quality
Director of Quality
Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12+ of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, Project Management (MS-Project) and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, Supplier Management a...
Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management
Operations Manager
Qualifications Profile Lean Green Belt certified professional with career-long expertise in manufacturing operations encompassing quality assurance, project and program management, budget control and allocation, new product development, and strategic planning. Drive operational productivity by integrating Lean principles and leading top-performing teams. Demonstrate adeptness at mentoring and motivating staff and personnel ...
Tags for this Online Resume: Manufacturing, Corrective Actions, Distribution, Electrophoresis, Engineering, Forecasting, Green Belt, Integrate, Inventory, Leadership
Aerospace Engineer - Near 85055
Seeing a Senior Executive Role in a solid company with a bright future.
Tags for this Online Resume: Change Agent, Lean Six Sigma, Warning Letter Remediation, Turn Around, FDA Expert, Senior Executive, Vice President Operations, vice President Quality Assurance, Vice President Regulatory Affairs, Chief Operating Officer, Chief Operations Officer, Chief Executive Officer
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
Medical Scientist
COVER LETTER: To whom it concerns: Please consider the following skill set: * Eleven years as the Medical Science Liaison (MSL) and Founding Chief Science Officer for Mitomics Inc (DBA as MTDNA Life Sciences), an Oncology Biomarker Discovery Company: o Worked with physicians to increase market uptake of company products o Helped design marketing material for both consumers and physicians o Researched oncology markets for hi...
Ideal Companies: Abbott, Sanofi
Tags for this Online Resume: Hematology, Oncology, Research, Magnetic Resonance Imaging (MRI), Market Research, MRI, Biopsy, Cancer, Dba (Database Admin), Urology
Operations Manager
HIGHLIGHTS OF QUALIFICATIONS Synergistic Solutions * SIX SIGMA Certification * Lean Management Initiatives * Process Analysis Proven Leadership Skills * Regulatory Compliance * Budgetary Oversight * Relationship Builder Strong Team Builder * Customer Service First * Successful Business Owner * On-Time Service Operations Excellence * Inventory/Shrink Controls * Expense Reduction * Profit Enhancement Effective, Creative Commu...
Tags for this Online Resume: Management, Project Management, Supply Chain, Packaging, Process Improvement, Quality, Quality Assurance, Quality Control, Logistics, Manufacturing
Compliance Manager - 20 Years of Experience - Near 78006
CAREER SUMMARY Management professional experienced in a broad range of quality control, quality assurance, regulatory and regulatory compliance functions within the pharmaceutical and medical device industry with over 35 years of experience. * Extensive experience in implementing quality systems to conform to regulatory standards to meet state, federal and international requirements. * Exceptional team leadership, auditing ...
Tags for this Online Resume: Manufacturing, Pharmaceutical, Quality, Quality Assurance, Quality Control, Audit, Diagnostics, API, Application Program Interface, Cardiopulmonary resuscitation (CPR)
Production Supervisor
Summary Manufacturing Professional - Solid experience directing and supporting multi-shift, cGMP/QSR production operations for medical device product lines in an FDA registered facility. Managed team of 60 employees and 3 supervisors. Responsible for compliance with FDA 21 CFR Part 820 and ISO13485 regulations. Character - a strong work ethic of integrity and honesty with perfect attendance Additional Qualifications High pu...
Tags for this Online Resume: manufacturing, reliability, production, Lean Manufacturing, Packaging, Disaster Recovery, Inventory, Sales, Allergy, Pharmaceutical
Scientist - 15 Years of Experience - Near 10954
SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...
Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, Filing, regulatory
Medical & Clinical Laboratory Technician
Summary of Qualifications: Growth-minded operational professional with a collaborative and innovative approach to problem solving. A proven ability to implement and execute project timelines, objectives, management and oversight of early phase global studies. Exceptional communication and relationship building skills allow continuous success with cross-functional, internal and external partnerships and stakeholders. * Diver...
Tags for this Online Resume: Management, Monitoring, Oncology, Protocol, Quality, Quality Assurance, Assessments, Filing, Financial, Planning
