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Online Resumes with "Capa"
Director of Quality - 15 Years of Experience
SUMMARY Certified Quality Auditor for Life Science Practice Lead as senior Quality System Auditor with compliance acumen delivering outstanding returns through comprehensive knowledge and hands on experience. Vendor qualification and management plus remediation efforts ensuring delivered products meet requirements for direct to stock fulfillment. Certified Quality Auditor/Project Manager for Quality Management Systems for m...
Tags for this Online Resume: Audit, Quality, Quality Assurance, Services, Test, Compliance, Infrastructure, Management, Risk Management, Training
Not Listed - 7 Years of Experience - Near 30046
Summary * Six Sigma project manager experienced working on process improvements on cross functional teams personnel * Recognized Rituximab density calculation error within LIMS Master Data and initiated appropriate CAPA remediation procedures which saved subsequent downstream lots from disposal * Analyzed, identified, and implemented cost savings opportunities for process improvement and operational excellence * Produced re...
Tags for this Online Resume: Process Improvement, Inventory, Management, Inventory management, Integrate, Operational Excellence, Process Improvements, Quality
Medical & Clinical Laboratory Technologist - 17 Years of Experience - Near 19335
SUMMARY OF QUALIFICATIONS For over 20 years a professional, with extensive experience in equipment applications, process/procedural development, and state-of-the-art technologies. Expertise specializing in: * Six Sigma Black Belt * Strategic Planning * Project Facilitation * Product Management * Implementation & Planning * Staffing & Team Development * CAPA & Root Cause Analysis * CAP/ISO Federal and European regulations
Tags for this Online Resume: Black belt, Diagnostic Imaging, Imaging, Pathology, Quality Assurance, Test, Management, CAPA, Applications, Audit, Regulatory, Laboratory
Department Manager - 19 Years of Experience - Near 18901
Tags for this Online Resume: Pharmaceutical, Good Manufacturing Practices, Management, Logistics, Summit, Training, LMS, Quality, Quality Assurance, Compliance, GXP/ DEA, E-Learning, CAPA, Investigations, Auditing, ICH, FDA, EU
Mechanical Engineer
Major in M.E. (MSME) minor in Ch.E. extensive industrial experience in Project Management (EPCM, Product and Process Development), Cost Engineering, Mechanical, Process and Manufacturing Engineering, equipment, material and engineering service oversea out-sourcing • Product/process design and development from conceptual to commercialization in electronic, pharmaceutical process, medical device, automotive, material, and con...
Tags for this Online Resume: EPCM, Project management, DFM/A, FMEA, DMAIC, Web handling, Powder and bulk solid, automation and Lean Sigma, TPM/RCM, Product and Process Development, Engineering Cost estimation/Budgeting, Inventory, Inventory Control, Front End Engineering
Quality Engineer - 14 Years of Experience - Near 01534
Maintain contracted to Gentex Optics - Dudley, MA * Maintain calibration database and run monthly calibration due lists * Coordinate calibration due list internally and with external calibration labs * Perform calibrations on internal optical instruments and standards * Perform internal quality system and process audits maintain logs and files * Perform CA & CAPA investigations and bring resolutions to a close * Coordinate ...
Tags for this Online Resume: Corrective Actions, Audit, Complaints, Manufacturing, Inspection, Document Control, Micrometers, Quality Assurance, Massachussetts
Director of Quality
Tags for this Online Resume: Corrective Actions, Management, Quality, Quality Assurance, Quality Management, Budgetary, Financial, Financial Services, Services, Manufacturing Engineer, Mechanical Engineer, CAPA, Process Development, Innovation, Medical Device, Regulatory, ISO, Molding, Automation, Design, Life Sciences, MRB, Strategic, IQ OQ PQ, TQM, 5S, 6 Sigma
Production Manager - 10 Years of Experience - Near 92656
Career Summary: * Working knowledge of FDA regulations, ISO standards, with the understanding of engineering disciplines and manufacturing. * Specializing in company Quality Management Systems (QMS). Revising the current document management systems and setting up new company wide Document Control Systems from the ground floor and up. * Design Mechanical, Electrical, Printed Circuit Boards and cables. With the ability to und...
Tags for this Online Resume: Quality, Document Control, Engineering, Management, Product Development, Support, Autocad, Autodesk AutoCAD, Baan, CAT
Production Supervisor
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices
Clinical Pharmacovigilance/Drug Safety
A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...
Tags for this Online Resume: BPI, Documentum, Document Control, Management, Project Management, Documentation Management, Pharmaceutical, Medical Device, Biotech
Engineer - 20 Years of Experience - Near 92591
SUMMARY Engineering professional with diverse experience in manufacturing engineering, quality engineering, and reliability engineering. Considered to have expertise in CAPA, DOE, statistical analysis (quality and reliability), equipment and process validation, test method design, 6M techniques and problem solving. Past products and peripheral areas include: angioplasty accessories, guide wires, dilatation catheters, metal ...
Tags for this Online Resume: Audit, Catheter, Manufacturing, Engineering, Manufacturing Engineering, Research and Development, Data Analysis, Purchasing, Reliability, SAN (Storage Area Network)
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
