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Online Resumes with "process validation"
Principal Quality Engineer, CAPA, New Product Development
Searching a position as senior/principal quality, manufacturing, R&D engineer focused in mitigation, remediation, redesign and process change for cost savings and product quality enhancement, CAPA initiation and execution, and new product development.
Ideal Companies: medical or Aerospace industries
Tags for this Online Resume: Manufacturing, Medical Devices, Product Development, Research and Development, R&D, IQ/OQ/PQ, Pfmea, Dfmea, Certified Quality Auditor, Six Sigma/ Lean Sigma Green Belt, Quality Foundation Deployment Green Belt, MiniTab, Managing Cross Functional Teams, Solid Works Design, Conceptual Design, New Product Development, Risk Analysis, Negotiations, Customer Relations, Value Engineering, Decrease Field Failure, Increase Customer Satisfaction, Report writing, Authoring and enhancing Standard Operating Procedure, ISO 13485, ISO 14971, ISO 60601-1, Authoring Quality Manual, Design Validation, Verification, Valves, Switches, Linkages and mechanism design and development, Complaint Handling
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer
Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology
Medical Device Operations Executive looking for the Next Challenge
Transformational Operations, Manufacturing and Engineering Services Leader with a demonstrated track record of driving successful change in the global medical device industry. - Design for Manufacturing (DFM) - Plant Start-Ups - M&A Integrations - Project Management - Operations & Supply Chain - New Product & Process Development - Document Control - Contract Manufacturing - Manufacturing Strategy - International A...
Ideal Companies: Medical Device
Tags for this Online Resume: Automation, Business Development, Capital Equipment, Critical Care, Documentation, Employee Relations
Data Mining Specialist - 0 Years of Experience
Jr Data Scientist/Analyst with deep expertise in statistical analysis, identifying trends, data mining and modeling, process validation and business needs analysis seeking an exciting opportunity. Proven ability to understand customer requirements, translate into actionable project plans, and deliver bottom line results in accordance with specified timeline. Reliable, responsive and dedicated with an endless passion for ana...
Tags for this Online Resume: Microsoft Excel, Accounting, Microsoft SQL Server, Structured Query Language, Ad hoc analysis, Automation, BASIC Programming Language, Billing, Business Intelligence, Cash Flow
Quality Assurance Director - 20 Years of Experience - Near 27962
Summary A Quality Assurance leader with 25+ years of cGXP expertise working in the Biotech and Commercial Pharma manufacturing industry. Extensive experience working directly with USA and EU CMOs/CTLs dealing with process drug development/ process troubleshooting, process validation, inspection readiness, and IMP distribution/ disposition. Successful FDA/EMA/ROW inspections and approval history with expertise leading global...
Tags for this Online Resume: Management, Utilities, CMOS, Audit, Quality Assurance, Test, Pharmaceutical, Process Engineering, Engineering, Packaging
Health Technologist - 0 Years of Experience
Well experienced in Medical Device Industry as Equipment Validation / Quality Engineer with strong background in New Product Development, Equipment Qualification, Manufacturing, Packaging, Process and Test Method Validation. * Good experience in analytical method validation using statistical tools. * Expertise and experience in developing and implementing Master Validation Plan (MVP), and in using six sigma tools like FMEA...
Tags for this Online Resume: Manufacturing, Assessments, Compliance, Management, ISO, Medical, Risk Management, Utilities, ASTM, CFR Part 11
Pharmacy Technician - 17 Years of Experience - Near 27330
Tags for this Online Resume: Data Entry, ISO, SAP, Troubleshooting, Manufacturing, PEDIATRIC, Chemistry, Pharmaceutical
Quality Assurance Director - 0 Years of Experience
Engineering professional with in depth work experience in lean manufacturing, process engineering, research and development, quality assurance, Quality System programs including CAPA, Audits, Supplier Quality, RiskManagement, Complaint Investigations and Document Control. * Experience in root cause analysis, developed testing strategies to support test executions, process verification/ validation, Assembly line, Current/new...
Tags for this Online Resume: Manufacturing, Product Development, Reliability, Root Cause Analysis, Statistical Analysis, Assessments, Compliance, Documentation, Engineering, Evaluate
Broadcast Technician - 20 Years of Experience - Near 10998
Strong track record of collaboration, creating effective partnerships across organizational lines and establishing leadership around shared organizational challenges. * Exceptional skill in managing and directing cross-functional project management teams that support commercial manufacturing organizations through sourcing strategy, technology transfer activities, process improvements, and process validation. * Instrumental...
Tags for this Online Resume: CATV, Appraisals, Customer Service, Encryption, Logistics, Networking, NOC, Real Estate, Root Cause Analysis, Satellite
Design Engineer
As a Design Engineer with over 9 years of experience, one of my goals is to oversee management of projects, develop one on one client relationships, and aspire to be closely involved in special project at senior project managers level, focusing on design intent.
Ideal Companies: Alberici Constructors, Emerson, General Motors, Boeing, Timet, Shneider Electric, AllCom, MiTEK, Cardinal Health, Graybar, Nestle Purina Pet Care Company, Peabody Energy, SAFC, Clayco Construction, Mallinckrodt Pharmaceuticals, and Anheuser-Busch-St. Louis.
Tags for this Online Resume: SOLIDWORKS, CAD, AUTOCAD