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Online Resumes with "Change control"



Clinical Quality Assurance

SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...

Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API

Network Administrator - 7 Years of Experience - Near 14208

Skilled strategist who transforms strategic plans into workable solutions and benchmarks performance against operational targets and goals. * Competent performer who can bring understanding of high-tech industry strategic business initiatives IT expertise and operational management experience to your organisation. Proven multi-disciplined IT development and administration skills and a major player in strategy formulation in...

Tags for this Online Resume: Disaster Recovery, Disaster Recovery Planning, Infrastructure, Planning, Security, Applications, Banking Industry, Business Development, Capacity Planning, Change Control

Quality Manager - 10 Years of Experience - Near 52601

Areas of Expertise * Continuous Improvements Corrective Action & Root Cause * Process Development ISO 9001/2008 - Lead Auditor * Data Analysis Six Sigma Green Belt Trained * Risk Analysis & Management Certified Internal Auditor * Change Control PFMEA's/SPC/PPAP/APQP * Team Development & Leadership Quality System Design & Management * Customer & Employee Relationships Safety/Regulatory Compliance Management Review Incoming I...

Tags for this Online Resume: Quality Documentation, ISO 9000:2008, ISO 9000:2015, Management, TQM (Total Quality Management), Six Sigma Green Belt, 8D Root Cause Analysis, Certified ISO auditor, Corrective Actions, PFMEA/SCP/PPAP's, Government Specifications, First Articles for Government

Application Support - 8 Years of Experience - Near 75181

Summary: * Developed and implemented processing tools that enhance daily and operational function for the I/T community and the end users. * Provided technical assistance to PMO managers, Business Analysts, Incident Control Managers (ICM), systems user support to programmers and customer support to end-users. * Performed project task and assist on a detailed technical level to ensure task and day to day functions are comple...

Tags for this Online Resume: Management, Ca7, Production Support, Disaster Recovery, EDI, Electronic Data Interchange, IBM, IBM MVS Operating system, Idcams (Data Mgmt Utility, Microsoft Access, Tivoli, Mainframe Batch

Vice President - 20 Years of Experience - Near 60467

Accomplishments Manufacturing Engineering: Drove the design and implementation of new lean automated manufacturing facilities, including fabrication, powder coating, and assembly operations in support of new product releases. Grew & developed a mature engineering organization to support operational requirements internally including automation, tool design, packaging design, and Tool & Die functions. Defined capacity plannin...

Tags for this Online Resume: Manufacturing, Management, Project Management, Product Development, Engineering, Reliability, Support, Black belt, Compliance, Quality

Production Supervisor - 4 Years of Experience - Near 97024

Finishing Assembly Responsible for all finished good commitments and deliveries out of Cincinnati site. Oversee planning and scheduling of six product lines with 200+ Finished Goods and 6000+ individual parts. * Planned the recovery of the stereotactic product line from >$650k backorder and 18% safety stock to $0 backorder and 94% safety stock in less than six months. * Prioritized the work of the Manufacturing, Quality, En...

Tags for this Online Resume: Manufacturing, Lifesciences, Audit, Engineering, Management, Medical, Medical Devices, Supply Chain, 5S, Change Control

Product commercialization professional - 20 years

To pursue a challenging position in a professional, fast paced organization by leveraging project management, teamwork, and new product launch experiences with business knowledge from MBA

Tags for this Online Resume: Project Manager, Consumer Pdts, PMP, Packaged Goods, PLM, Quality Systems, Change Control, Product Launch, Management, Assessments, Business Planning, Infrastructure, Planning, Product Lifecycle Management, SAP, Consumer Products, Cross-functional Team Leadership, Development Activities, Integrate, Leadership, quality management systems, training

Tester - 4 Years of Experience - Near 07034

Summary: 4 years of experience as a QA/Support Analyst in complete Software Development Life Cycle (SDLC) Process and Expertise in L1 L2 support and QA activities * 4 years of experience in the Information Technology as a support engineer * In depth experience in change management activities, specifically relating to process documentation raising RFC and documenting various test cases * Well Acquainted with the whole softwa...

Tags for this Online Resume: Test, Applications, Business Requirements, Integrate, Quality, Quality Center, Regression Testing, Structured Query Language, Support, Test Cases, QTP, HTML, AGILE, sql, agile, software, it jobs

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

Application Support - 20 Years of Experience - Near 23141

PROFESSIONAL SUMMARY Accomplished results oriented application support engineer with over 32 years of comprehensive Information Technology experience. Extensive experience in global incident management, implementation, security, change control processes and automation solutions.

Tags for this Online Resume: Procurement, Application Support, Change Control, Information Technology, Itil, Support, Consumer Lending, Data Entry, Infrastructure, Integrate, Security, Customer Service

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