A Quality Assurance and Regulatory Compliance leader with over 17 years of hands-on experience in Class I, II and Class III cardiovascular medical devices (implantable defibrillators), disposable products, patient monitoring devices, mobile medical devices/apps and combination drug/device products. Held various positions with increasing authority and responsibilities in management and functions which have led to comprehen...
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Quality Assurance / Operations , CAPA Management , Process Engineering , Change Control , Internal / External Audits , Lean /Six Sigma, Quality System management, Complaint management
Skilled in the planning and implementation of clinical research projects in compliance with ICH-GCP, Regulatory Agencies, and company SOP. Study Start up expert.
Proficient in Microsoft Office Applications, CTMS, IVRS/IWRS, INFORM, Medidata Rave.
Therapeutic areas: Oncology, Cardiology, Neuroscience, Internal Medicine, including Diabetes.
Participated in 3 FDA Submissions, FDA Inspection Readiness and TMF reconciliation
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Princeton, Study startup, In house CRA, CTA, Inform, Medidata Rave
Summary of QualificationsDedicated, hard working, and enthusiastic leader with over 10 years of experience in restaurant management and airline catering. Expertise in strategic planning, managing operations, improving efficiency of operations, and team building. Capable of identifying areas of strengths and weakness as well as implementing company policies, standards, changes in operations, and restaurant systems that optim...
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Airlines, Process Improvements, sheets, Complaints, Quality, Quality Assurance, Test, Management, Communication Skills, Dec
Summary Accomplished Quality Assurance Professional with extensive experience in developing, implementing, and successfully sustaining quality management systems in various manufacturing companies including virtual pharmaceutical facilities, while assuring local and international regulatory compliance. Proven expertise in developing quality improvement plans, supplier management programs, auditing, streamlining procedures a...
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Management, Process Improvement, Risk Management, Disaster Recovery, Kaizen, Manufacturing, 3PL, Audit, Packaging, Quality Management
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...
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Audit, Quality, Quality Assurance, Services, Test, Compliance, Infrastructure, Management, Risk Management, Training
Professional Summary A certified professional Clinical Research with 4 years of experience in Clinical Research coordination and a year experience as Clinical Study Associate. Expertise in QC of documents, remote Monitoring and supporting the management by handling the tasks of multiple clinical research studies managing eTMF's & designing Clinical Portfolio's from Sponsor end. Expert in liaising between different departmen...
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Document Management, Monitoring - Remote and onsite, Clinical Research coordinator, Device trials, clinical Research, Project Management, QC and QA, Pharmacovigilance, Ethics and compliance, regulatory, Clinical study Associate, Multiple therapeutic areas experience, Phase 1-4 trials, Audits and Inspection readiness, Multiple software and application experience - Veeva VAULT , Impact , Quest , Sentinel,Tesla, EDC experience- RAVE Medidata, IRT system experience Clinpace , Endpoint
SUMMARY Highly motivated Quality Professional with over 15 years' combined working knowledge in Quality System Regulations (QSR), Quality Management System (QMS), FDA Inspection Readiness, and Systems Based Auditing with varied cGMP, cGLP, Nonconformance and CAPA Management experience. Experience in regulated environments for Pharmaceutical, Medical Device, Biologics and Bio-Chemical industries. Demonstrated strengths in or...
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Complaints, NCR, Test, Audit, Facilitator, Green Belt, High Performance Liquid Chromatography (HPLC), Logistics, Quality, Quality Assurance, Corrective action preventive action, steel, mechanical engineer, die cutting, machine operator, electrical engineer, CAPA, Risk Analysis, FMEA, Control Plans
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...
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Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting
SUMMARY: * rn, bsn, cpm, * Over 28 years of Clinical Research experience * Respiratory, Ophthalmology, Oncology, Infectious Disease, Cardiovascular, CNS and Gastrointestinal * Phase I, II and III experiences * 14 years of Clinical Trial/Project Management experience * 4 years of field monitoring experience * 14 years of experience providing oversight to CTAs and CRAs PurDue PharmA July 2017 - present Sr Clinical Project Man...
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Clinical Research, Research, Distribution, Project Management, Project Manager, Integrated Development Environments, Protocol, sheets, Management, Biomedical Industry
