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Online Resumes with "cGMPs"
Senior Manager / Director of Quality
Summary of Qualifications: * Twenty Eight +, years of experience in molecular biology, protein chemistry, biotechnology sciences, QC management, Regulatory Affairs, and Quality Assurance. * Experienced in establishing and directing groups, project management, assay development, personnel training and supervision, quality control, and regulatory cGMPs. * This combination of skills affords a unique opportunity to guide the Qu...
Tags for this Online Resume: Audit, Compliance, Biotechnology, Due Diligence, Licensing, Insurance, Microbiology, Benefits, Documentation, Chemistry
Quality Systems Specialist - 20 Years of Experience - Near 94545
Summary * Multiple years' experience and thorough understanding of technical and business requirements for Biotech in clinical and commercial multi-product manufacturing facility. * Knowledge of regulatory expectations and requirements for protein purification facilities and industry standards and practices, manufacturing processes, cleaning validation, safety principles, quality systems, cGMPs, engineering design fundament...
Tags for this Online Resume: GMP, Troubleshooting, NPI, Change Control, Data Analysis, Management, Manufacturing, Product Development, Quality, Quality Assurance
Production Inspector
Professional Summary Skills Team leadership, supervisory Quality control, auditor, Kanban s k ills inventory, cycle counting, clean room, line clearance, food industry production, pharmaceutical packaging, data entry, documentation Automotive production/assembly cGMPs, cSOPs, familiarity with operations, plastic injection mold, OSHA, FDA, ISO quality standards, hard-coating lens, metalizing 5s. safety components, ability to...
Tags for this Online Resume: Clean Room, 5S, Automotive, Billing, Communication Skills, Data Entry, Distribution, Documentation, Inventory, ISO, Team Lead, Quality Control, GMP, FDA, OSHA, CHARLOTTE, NC, Customer Service
Quality and Regulatory Compliance
SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...
Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services
Materials Scientist - 20 Years of Experience - Near 27597
SUMMARY Seeking Challenging Scientific /Engineering role with Chemical Engineering, Business Management degrees and 25+ years experiences in process/project/manufacturing/quality engineering in Fortune 500 companies in the United States. * Excel in process technologies for extrusion & molding of plastic & rubber manufacturing. * Experienced (hands on) in: Medical Equipment, Automotive, Rubber Compounding, Plastic, Glass, Fl...
Tags for this Online Resume: Heat Exchangers, Product Development, Corona, Quality Assurance, Engineering, Green Belt, Injection Molding, ISO, Medical, Plastics
Quality Coordinator - 20 Years of Experience - Near 00705
Summary of Over 39 years of successful experience in Quality (Quality Assurance/Quality Qualification Control/Quality Operation) in the pharmaceutical and medical device manufacturing area. Strong knowledge of investigations and CAPA. Excellent knowledge in cGMPs, Incoming inspection, complaints handling, validations, change control, packing material, manufacturing and packaging area. Strong leadership, negotiation, communi...
Tags for this Online Resume: Filing, Management, Packaging, Audit, Injection Molding, Policies and Procedures, Quality, Quality Assurance, Quality Management, Medical, healthcare, Healthcare
Manager - 10 Years of Experience - Near 91387
QUALIFICATIONS * Customer-focused / diplomatic / tactful / positive / upbeat * Superior Manager / coach / trainer / mentor / solution-oriented / highly organized * Persuasive oral / written communicator / high level of motivation / aptitude * Interact well at all levels internally and externally / excellent stability * Adept Team Leader or function well as an individual contributor * Resourceful problem solver / outstanding...
Tags for this Online Resume: Compliance, Distribution, Test, Collection, Team Lead, Customer Service, Flooring, Inventory, Inventory Control, Retail, assistant manager, management
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Clinical Regulatory Affairs - 2 Years of Experience - Near 02215
PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...
Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH
Chemist
QUALIFICATIONS * Ability to participate in development, optimization, and validation of analytical methods. * Project leader: responsibility for projects, e.g. method improvements, implementation of new methods and instrumentation. * Extensive knowledge and skills in telecommunication project management and customer service. * Ability to record, analyze, review data, maintain analytical lab instruments and laboratory suppli...
Tags for this Online Resume: Appraisals, Support, Wireless, Data Entry, Management, QA/QC, AT&T, Ethernet, Internet, OC-3, chenistry
Production Manager - 20 Years of Experience - Near 32825
PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...
Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management
Clinical Quality Assurance - 20 Years of Experience - Near 19021
SUMMARY OF QUALIFICATIONS: Capable and accomplishment driven individual, with over 20 years of experience in the Pharmaceutical / Drug Development Industry. A flexible problem solver with excellent written and interpersonal communication skills and a dependable team member at both associate and management levels with recognized achievements in the following areas: * Operational experience and management in Primary and Secon...
Tags for this Online Resume: Compliance, Packaging, SharePoint, Sharepoint Technologies, Data Entry, Management, Project Management, Capital Assets, Assessments, Audit, physical therapist, pharmaceutical, trial, clinical
