CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "cfr"

Manager - 20 Years of Experience - Near 46033

Summary of Qualifications: Senior hands-on IT Manager with successful record of accomplishments in IT infrastructure management, data center design, security, and virtualization. Ability to rapidly align with mission critical initiatives, envision enterprise-wide solutions, deploy cost effective methods, and engaging high performing talent to exceed expectations. Recognized for strength in areas of team building, motivation...

Tags for this Online Resume: Lan/Wan, Lead Generation, Leadership, Local Area Network, Wide Area Network, Active Directory, CFR Part 11, Cisco, Cisco PIX Firewall, Firewall

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

Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry

PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...

Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device

Electrical Tester - 14 Years of Experience - Near 60534

Seeking a challenging and rewarding career opportunity in the Maintenance/Electrical Field where my education, experience, and capabilities would be of value. Work History CATERPILLAR/Electro Motive/Electrical Tech. Installation. /La GRANGE, IL/5/11- Present. Work with engineering, final test, and inspection. Wiring and installing equipment in high and controlled voltage applications. Find engineering on other tech problems...

Tags for this Online Resume: Hydraulics, Welding, Capital Equipment, CNC, Electronics, Low Voltage, Manufacturing, Purchasing, Valves

Biological Technician - 18 Years of Experience - Near 02421

SUMMARY Quality Control Chemistry works, Internal/External Audits and Inspection, Maintain Laboratory update with Quality Management. Technical work and knowledge of Biotech/ Pharmaceutical QC/QA system with cGMP and GLP compliance, Practice Quality Management and ICH regulations guided by ISO 9000+. Complete COA for drug product and biologics. Maintain liaison with contract manufacturing (CMO/CTL) Operation and collect bat...

Tags for this Online Resume: CFR Part 11, Inventory, ISO, ISO 9000, Troubleshooting, Audit, Change Control, Chemistry, Documentation, pharmaceutical

Production Supervisor - 9 Years of Experience - Near 53216

To strive for excellence, to work in such an environment that will enhance my knowledge and career, where I can p erform my management and 49CFR/IATA skills according to my strong Caliber and efficiency.

Tags for this Online Resume: Distribution, Transportation, Forklift, Inventory, Material Handling, 5S, Coaching, Customer Focus, Focus, Leadership, Supervisor

Quality Manager - 20 Years of Experience - Near 29707

Various positions and contract engagements dealing with preparation and data collection for special processes under 10CFR50 Appendix B and ASME Section IX programs. These positions include clerical, regulatory and mechanical duties.

Tags for this Online Resume: Documentation, Quality Assurance, Technical Writing, Test, ANSI, Ansi (Am Natl Stds Inst), Management, Technical Documentation, 10CFR50, Business Analysts, Procedure Coordinator

Mental Health Therapist - 16 Years of Experience - Near 32701

SUMMARY OF QUALIFICATIONS Background: * Supervised and trained staff * Oversee the day to day operations of the program/facility to include plant operations, support services, nursing and health services, and administration. * Program budgeting and issued monthly invoices as well as reports. * Initiated program planning and wrote funding proposal program * Designed and implemented educational training programs * Planned, or...

Tags for this Online Resume: Clinical Programs, Compliance, Development Activities, Documentation, Planning, Policies and Procedures, Services, Support, Training, Computer Aided Software Engineering

ERP - 20 Years of Experience - Near 47630

Summary of Experience and Qualifications * SAP Transformation professional with more than ten years of SAP experience (3 full life cycles), in Consumer & Pharmaceutical Products * Strong Project Management experience in managing multiple medium to large SAP projects ($1 million - $4.5 Million), forming & performing large teams through various stages * SAP Max Attention management, SAP custom engagements: o Success Factors, ...

Tags for this Online Resume: Software, Application Architecture, Management, Pharmaceutical, Business Management, software, SAP, HANA, CONSUMER PRODUCTS

Chemist - 20 Years of Experience - Near 84341

Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...

Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface

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