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Online Resumes with "cgMP"



Operations Manager - 10 Years of Experience - Near 91360

Qualifications Director of Operations responsible for manufacturing products in accordance to specifications, regulatory requirements in high volume/capacity production plants. Directly reported to founder of company and Board of Directors. Senior Clinical Project Manager with 5+years' experience in running medium to large scale complex projects for R&D, Manufacturing of medical compounded products, and processes related to...

Tags for this Online Resume: six sigma, compliance, cgmp, Document Management, Quality Control, Stability, CMOS, Enterprise Resource Planning, Management, Management Review

Quality Manager - 20 Years of Experience - Near 37064

Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...

Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions

Quality Control

SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...

Tags for this Online Resume: Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits

Production Tester - 10 Years of Experience - Near 07076

SUMMARY: Over eight years of experience in Analytical Chemistry. Extensive knowledge in the operation and trouble shooting of HPLC, GC, AA and UV. Tested a wide variety of finished and raw materials products for cosmetic, pharmaceutical healthcare and environmental companies to ensure compliance and regulations following SOP's or appropriate compendium method procedures. Managed multiple tasks efficiently and effectively. P...

Tags for this Online Resume: Inventory, Generate Reports, High Performance Liquid Chromatography (HPLC), Manufacturing, Audit, Compliance, ISO, SAP, Analytical Chemistry, Chemistry, manufacturing

ERP

Experienced with FDA cGMP and related regulations and guidelines with knowledge of computer validation methodologies and principles * Expert knowledge of tools and accelerators such as Solution Manager, SAP Infopak, HP ALM (Mercury System), * Expert configuration knowledge of SAP Planning and Manufacturing (PP PP-PI REM) MM Materials Management, Quality Management QM Batch Management, Classification with cross-functional kn...

Tags for this Online Resume: Business Development, Inventory, Inventory management, Management, Procurement, Acquisitions, Application Support, Computer Aided Software Engineering, Consulting, Distribution, it jobs, software, agile

Director of Quality - 20 Years of Experience - Near 75063

Accomplishments included significant reductions in customer complaints, up to 50% over 60% reduction of rework increase in percentage Right-First-Time, to reach RFT >99% recalls prevention reputable audit certifications plant readiness for audits. * Promoted from Quality Assurance Manager to Plant Manager after a few months in the company due to the immediate impact on the organization's transformation from an environment o...

Tags for this Online Resume: Compliance, Quality, Quality Assurance, Quality Control, Test, Audit, Complaints, Consulting, Defense, Internal Auditor, manufacturing, Director and consultant of food safety and quality

Pharmaceutical Sales Representative - 19 Years of Experience - Near 01746

Summary Highly motivated, dedicated and results oriented sales and marketing professional with over eighteen years experience in Contract drug development and manufacturing, Engineered process equipment and Separations Technologies. Global thinker with strong business development experience. Dynamic self- starter with outstanding leadership and communication skills collaborating with multicultural, cross- functional teams t...

Tags for this Online Resume: Sales, Sales Engineer, Business Plan, Engineering, High Performance Liquid Chromatography (HPLC), Process Engineering, Heat Exchangers, HVAC, Mining, Pharmaceutical Industry, ACCOUNT DIRECTOR, DRUG DEVELOPMENT

Quality Manager - 12 Years of Experience - Near 19120

I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...

Tags for this Online Resume: Documentation, Manufacturing, Integrate, Oracle, Graphical User Interface, Intranet, Microsoft Visio, Microsoft Visio Professional, Microsoft Word, Statistical Analysis, Technical Writer, Documentum, Sharepoint, Trackwise

Chemist - 9 Years of Experience

Summary * Take a challenging, creative role to work in the field of Chemistry and implement the expertise in development and analysis of quality compounds efficacious for the organization * Experience in Quality Control of the raw materials to manufactured product * Experience with HPLC, IR, Chromatography, UV - VIS spectroscopy instruments * Familiar with Wet Chemistry Techniques including pH testing, Viscosity testing and...

Tags for this Online Resume: Chemistry, Analytical Chemistry, BIS, ISO, ISO 9001, Quality, Quality Assurance, Test, Documentation, Notebook Computer

Clinical Quality Assurance - 20 Years of Experience - Near 46360

Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...

Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance

Purchasing Agent - 20 Years of Experience - Near 14626

PROFESSIONAL SUMMARY Over twenty years of self -motivated and hands-on experience in a broad range of commodities and services on a global basis in many industrial manufacturing environments including strategic sourcing, purchasing, contract negotiation and management, and Supply-Chain management. Extensive experiences are in project management, strategic planning, lean process and execution, cost analysis and contract nego...

Tags for this Online Resume: Electronics, Government, Inventory, Inventory Control, Laptop Computer, Logistics, Marketing Management, Purchasing, UL, Automotive

Chemical Technician

of Proficiencies * Quality Control * Regulatory Compliance * Procedural Implementation * Internal Audits * Document Control * cGMP Compliance * Learning Management System * FDA/DEA/PDMA Regulations * Technical Writing

Tags for this Online Resume: Compliance, Document Control, LMS, Microsoft, Microsoft Access, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Quality