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Online Resumes with "FDA COmpliance"



Engineering Manager - 20 Years of Experience - Near 85308

I am interested in making contributions to your enterprise as a Product Manager, Engineering Manager, Director of Operations. I have a wealth of experience in New Product Development, Current Products Engineering, Industrial & Manufacturing Engineering - Steel Manufacturing, Steel Tube Manufacturing, Lean Process Improvement Design & Implementation - Operations Capacity Planning - Facility Layout Design - Production Contro...

Tags for this Online Resume: Continuous Improvment

Featured Profile

Senior Technician 19 years pharmaceutical/biotech excellence

Senior Level Technician managing teams and optimizing autonomous tasks with precision. Brilliant technical leader delivers shareholder value to the most prestigious global organizations.

Ideal Companies: Novo Nordisk, Wyeth, Moen, Glaxo Smithkline, , Philips, Deidre Moore, novartis, AAIPharma, Catalent, SAS

Tags for this Online Resume: supervison, metrology, instrumentation and controls, deltaV, SCADA, pharmaceutical, troubleshooting, Project Leader, Project Management, Instrumentation

Featured Profile

Senior Process Validation Lead

Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.

Featured Profile

Production Supervisor - 18 Years of Experience - Near 90041

Summary Qualified manufacturing supervisor with 10 years production experience, professionally skilled in leading high productive team, using lean manufacturing principles to reduce cost and increase process efficiency. In-depth knowledge of cGMP regulation and FDA compliance. Dedicated leader with demonstrated ability to train, manage and motivate team members to achieve organization goals and objective. Accomplishments Pl...

Ideal Companies: A growing or prominent biopharmacuetical company. Gilead, Amgen, Roche, Kite, Novartis

Tags for this Online Resume: Management, Quality, Quality Assurance, Quality Control, Inventory, Manufacturing, Corrective Actions, Lean Manufacturing, Production Planing, ISO 8 environment, Chaired Daily QIT meetings

Clinical Regulatory Affairs - 9 Years of Experience - Near 07062

To gain a position wherein my training expertise, organizational and computer skills will be utilized effectively as an asset to overall organization.

Tags for this Online Resume: Documentation, Pharmaceutical experience, software support , FDA compliance , pre-clinical, Documentum, regulatory, LMS, Applications, Integrate, Lotus, Lotus Notes, Microsoft Frontpage, Microsoft Office, Microsoft Project, Electronic Publisher

Clinical Quality Assurance - 15 Years of Experience - Near 33983

PROFILE: With over 20 years in supervisory management and individual contributor positions within the Quality discipline, and 15 years with Customer Service; I have a total of 35 years of cGMP/GxP industry knowledge working within both in Commercial and Development environments (Virtual). My career spans both the Quality and Customer Service arenas and is supported by my skills in chemistry, mathematics, and business. My ex...

Tags for this Online Resume: New Hampshire , Chemistry, FDA Compliance, GMP Auditor, Team Building

Scientist - 8 Years of Experience - Near 95695

PROFILE: 8+ years of success in biologic research, data analysis, project management and leadership, scientific writing and editing, teaching and mentorship, and collaborative biomedical-based engineering in university and lab settings. * 6 research publications, highlighting advancements in bone tissue engineering and biopharmaceutical delivery. * Podium presentations at seminars and conferences focusing on scientific netw...

Tags for this Online Resume: Manufacturing, OSHA, Research, Cellular, Good Manufacturing Practices, Project Management, Project Manager, Biomedical Engineering, Materials Science, Biomaterials, Science, Biomedical, Pharmaceutical, Cell culture, Scaramento, Tissue engineering, Tissue culture, Laboratory

Medical & Clinical Laboratory Technologist - 10 Years of Experience - Near 30087

QUALIFICATIONS Blood Banking * Hematology * Chemistry * HIV Testing * Herpes Antigen Testing * Toxicology * Serology * Syphilis Testing * Cytomegalovirus (CMV) * Quality Control Experience * Quality Assurances * Procedures & Documentation * Knowledge of CAP, CLIA and FDA Compliance and Guidelines * Lab Testing & Reporting.

Tags for this Online Resume: Compliance, Documentation, Good Laboratory Practices, HIV/CMV/ABO/Rh, Medical Analysis, Occupational Safety and Health Act, OSHA, OSHA Regulations, Quality Control, Chemistry

Quality Manager - 11 Years of Experience - Near 07077

Areas of expertise: Product Development - Outside Sourcing - Vendor Relation Interaction - Suppliers Interactions - Management - Personal Development Growth of Team Members- Quality Systems Consultation - Strategic Planning - Deviation Investigation - FDA Compliance - Root Cause Analysis - Budgeting Needs Assessment - Customer Service - Process Improvement & Optimization -Quality Assurance -Project Management - Audits Produ...

Tags for this Online Resume: Packaging, Quality, Forklift, OSHA, Toxicology, Management, Audit, Compliance, Computer Aided Software Engineering, Documentation

Quality Assurance Director - 13 Years of Experience - Near 60453

SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...

Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management

Not Listed - 20 Years of Experience - Near 91740

SUMMARY An analytical and detail-oriented healthcare professional, with extensive experience in nursing, biotechnology, regulatory compliance, global safety, pre- and post-market studies, research and development, clinical trials and FDA compliance. Utilizes exceptional organization and communication skills to consistently set and meet high-quality standards. Possesses a proven ability to utilize a cross-functional skill se...

Tags for this Online Resume: Complaints, Coding, Compliance, Manufacturing, Medical, Oncology, Pharmaceutical, Policies and Procedures, Quality, Quality Assurance

Materials Scientist - 20 Years of Experience - Near 27597

SUMMARY Seeking Challenging Scientific /Engineering role with Chemical Engineering, Business Management degrees and 25+ years experiences in process/project/manufacturing/quality engineering in Fortune 500 companies in the United States. * Excel in process technologies for extrusion & molding of plastic & rubber manufacturing. * Experienced (hands on) in: Medical Equipment, Automotive, Rubber Compounding, Plastic, Glass, Fl...

Tags for this Online Resume: Heat Exchangers, Product Development, Corona, Quality Assurance, Engineering, Green Belt, Injection Molding, ISO, Medical, Plastics