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Online Resumes with "change control"
Quality & compliance professional with 24 yrs of experience
With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...
Tags for this Online Resume: Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809
Manager - 20 Years of Experience - Near 76574
• Over 20 years as an Operations professional, working with both commercial and high reliability requirements • Experience in all aspects of electronic assembly: Manufacturing engineering, change control process, new product introduction, drawing review and approval, part number and bill of material (BOM) creation, component AVL, component spec review and production support • Highly skilled in problem solving / Excellent co...
Tags for this Online Resume: ERP System, Bill of Materials, Change orders, Engineering Tech, Office, Manufacturing, Supervisor, Manufacturing Spport
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Quality Engineer - 14 Years of Experience - Near 91016
Over14 years of in-depth experience in the pharmaceutical industry. Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation
Project Manager - 16 Years of Experience - Near 20708
Project Management: • Works with customers to develop project scope of work documents and project plans. • Uses project management skills to manage project roles, identify resource requirements, • Defines project deliverables, provide customer satisfaction and reporting structures and insure quality of projects. • Identifies the technical approach to be used on a given project and manages the solution development pr...
Ideal Companies: Lockheed Martin, Northrop Grumman, Google, DHS, DOD, FEMA
Tags for this Online Resume: Assessing, Analyzing, Monitoring, Selecting, Determining, Writing, Planning, identifying, Ensuring, communicating, ITIL Foundation, Six Sigma Green Belt, Human Resource, Contracting, Microsoft, Analysis, Project Manager, Business Analysis, Policy Planning, Security, Systems Analysis, IT Policy and Planning Analyst, IT Program Management Specialist, IT Auditor, Information Technology Architect, Information System Security Analyst/Specialist, Information Systems Security Officer, Change Request, Conflict Resolution, Responsibility Assignment, Risk Management Plan
ITIL Service Management Analyst - 4 years Experience - Houston
I am a certified professional with an extensive 3+ years experience in ITIL Service Management, Business Administration and Service Desk Technical support. Significant knowledge in optimizing business processes, determining and suggesting the best practices, strategies, policies and standards for the enhancements in the industry,driving change initiatives and transitions,managing and administering production and development...
Tags for this Online Resume: Houston, ITIL Service Management, Change Management, Problem Management, Asset Management, Incident Management, ITIL V3 certified, ITIL Intermediate (Service Operation) certified
Sr. Consultant/Infrastructure Project Manager
Directed high-level Infrastructure projects between vendors, clients, business units and IT staff members. Project manage infrastructure requirements both hardware and software to comply with service level agreements. Support application deployment, QA testing, project estimation, planning, data gathering, project tracking, process improvements, and change control.
Tags for this Online Resume: VMware server ESX, , EMC Symmetrix, Infrastructure Manager, Consultant Proj Mgr, Sr Project Manager , Disaster Recovery, Global Infrastructure
Business IT Leader with 20 plus years of Experience - Clearwater Florida
Over twenty years of results-oriented success in a diverse range of leadership, change management, software engineering, education/training and coaching positions in highly competitive, diversified organizations. A Lifelong learner and seasoned leader who is dedicated to advancing organizations to higher levels of excellence through the optimal use of personal accountability programs, quality improvement initiatives and ...
Ideal Companies: Raymond James, AHS, Florida Hospitals, Citi, Tech Data, Jabal, Chase
Tags for this Online Resume: ERP oracle/peoplsoft, EMR EPIC, All scripts EPSi, Kronos, BI analytics, Application development , Project leader, Program Director, Director, SDLC, CRM, Decision Support, Revenue Cycle, Business Solutions, Coaching, Enterprise Data Warehousing, Change management
QA ASSOCIATE - 3 Years of Experience - 08873
• Ensure implementation of cGMP, GLP and GDP • Monitoring processing and laboratory activities in the facility on a daily basis • Hosting regulatory audits • Member of internal audit team • Preparation and implementation of Standard Operating Procedures, Stability Protocols, Master Batch Production Records, etc. • Evaluation and Qualification of vendors for raw materials, packaging materials and contract services • Samplin...
Tags for this Online Resume: QUALITY ASSURANCE, QA TECNICIAN, VALIDATION, DOCUMENTATION, QA AUDITOR, BMR, Test, Audit, Documentation, Internal audit, Manufacturing, Microsoft, Microsoft Office, Packaging
Pharmacist w/ Management, Prior authorization, Formulary Management and Managed Care experience
A Registered Pharmacist in OH, KY, CT, NY and MA with strong analytical and problem solving skills. Proven ability to multi-task, work autonomously, manage projects and a diverse set of responsibilities, 10+ years of management experience. Team player who works well with cross functional groups and adapts well to changing environments. Skilled in building excellent relationships with a wide audience from support and pharmac...
Ideal Companies: United Healthcare, Anthem, Express Scripts, Humana, Mercy Healthcare,
Tags for this Online Resume: prior authorization, medicare, pharmacist, managed care, project management, six sigma, Cincinnati, long term care
Project Manager, PMP - 10+Years of Experience - Open to Orange & Los angeles County position
Detailed-oriented Project Manager with proven record to deliver detailed and accurate results on tight schedule. Quality Assurance Gatekeeper who identifies and resolves potential defects to assure client satisfaction. Highly accomplished leader with expertise in hardware and software quality assurance, program management, regression and feature testing within cloud computing, data warehouse, Big Data Analytics industries...
Tags for this Online Resume: Teradata database, PMP, SQL, Linux, SDLC, Lean Six Sigma, Data Warehouse, Quality Assurance, Automated and Manual Testing, Data Analytics
Clinical Quality Assurance -13 Years of Experience - Near 92121
Experienced Document Control Associate for the pharmaceutical, device and technology industry working in a GLP, GCP, and cGMP environment. Demonstrated project manager for several document management types, with ability to self-prioritize to meet management and customer demands. Responsible for the successful execution of change control activities for all document types. Effective communicator with strong grammatical, wr...
Tags for this Online Resume: San Diego, CA, GLP, GCP, cGMP, Document Control, Quality Assurance
