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Online Resumes with "cfr"



Safety Engineer - 20 Years of Experience - Near 45069

ACCOMPLISHMENTS Associate of Applied Science in Occupational Safety and Health Qualified person Fall Protection. With Competent & Qualified person Certifications form Capital Safety. Qualified as a safety manager for all construction industries, powerhouses, paper mills, and steel manufacturing plants. The first structural steel erecting company in Ohio to implement 100% positive fall protection, random drug and alcohol tes...

Tags for this Online Resume: Construction, Policies and Procedures, Audit, Cardiopulmonary resuscitation (CPR), First Aid, Insurance, Manufacturing, project manager

Quality Coordinator - 6 Years of Experience - Near 60504

PROFESSIONAL SUMMARY: * Total of 9.5 years of experience in Health Care industry. 6 years' experience in Clinical Data Management. * Worked as a Clinical Data Coordinator in Quintiles Technologies from Feb 2011 to Aug 2014. * Worked as a Clinical Data analyst in PAREXEL International from Aug 2008 to Feb 2011. * Also, I have 3.5 years of experiences in Medical Microbiology field in health care sector I started my career as ...

Tags for this Online Resume: Data Management, Health Care Industry, Management, Microbiology, physical therapist

Quality Engineer

Summary To contribute my Engineering, Management, Client service, Computer Application, Continuous process improvement, quality management, and manufacturing operations expertise to a successful and growing organization. Expertise * Significant expertise with Continuous Improvement and Quality Tools, including Histograms, Pareto, Gantt Charts, and Flow Diagrams * Lean Manufacturing and Kaizen Event experience * Proficiency ...

Tags for this Online Resume: Quality Assurance, Training, 5S, CMM (Capability Maturity Model), Kaizen, R&R Report Writer, Data Analysis, Failure Analysis, Management, Root Cause Analysis

Automation & Control Systems Expert - 20 Years of Experience - Near 06375

QUALIFICATIONS Mr. Sincali has 30+ years experience in project design, programming, & commissioning of distributed automated control systems, electrical energy generation/monitoring/remote distribution control, CNG gas detection systems, pharmaceutical batch processing, paper/pulp mills, water/wastewater treatment SCADA and other advanced process control system applications. Recently, he has successfully implemented many la...

Tags for this Online Resume: Consulting, CT, Ethernet, Pharmaceutical, Automation, Assessments, CFR Part 11, Customer Accounts, Engineering, Hazardous Waste, distributed control systems, expert in PLC, control systems, project engineering

Featured Profile

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

Electrical Engineer - 11 Years of Experience - Near 10930

Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...

Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery

Lawyer - 12 Years of Experience - Near 21146

I am Maryland attorney with 10 years of experience in both litigation and transactions. I have also acted as general counsel to large scale government entities. I have a background in government, corporate, and civil law.

Tags for this Online Resume: Behavioral Health, Drafting, Fraud, Government, Information Technology, Procurement, Purchasing, Litigation, Family Law, AT&;T, Compliance, Regulation, Contracts, Privacy, HIPAA, 42 CFR Part 2, 1983 Cases, Federal, State, Local, Regulatory, Enforcement, Research, Legislative Drafting

Laboratory Manager - 18 Years of Experience - Near 28037

Qualifications Summary Laboratory Manager with extensive experience in regulated pharmaceutical manufacturing and research and development with more than 10 years of management experience. Thorough understanding of regulated Laboratory environments including but not limited to GMP, GLP, GDP and 21 CFR Part 11. Quick learner with proven track record of driving success. Skilled at navigating FDA and vendor audits. Implemented...

Tags for this Online Resume: Project Leader, Project Management, Budgetary, Drafting, High Performance Liquid Chromatography (HPLC), Management, Planning, Rational, White Papers, clinical, phase, trial, gcp, protocol, pharmaceutical, Quality, LC/MS

Life Scientist - 20 Years of Experience - Near 02642

SUMMARY IT/QA PROFESSIONAL Biotech - Pharmaceutical - Medical Device - Life Sciences Highly skilled consultant and Project Manager with diversified domestic and international experience and a background that incorporates strong technical orientation with business skills. Hold proven record of success in product development, process improvement, cGMP compliance, validation and quality control. Examples: * Software Implementa...

Tags for this Online Resume: Software, Compliance, HVAC, Management, Support, Assessments, Automation, Integrate, Manufacturing, Millenium (Sw-Fin/Admin), gcp, pharmaceutical, sas, protocol, clinical

Case Management Manager - 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

Safety Manager - 20 Years of Experience - Near 79924

Areas of Expertise * OSHA 29 CFR * OSHA 49 CFR * OSHA Health Safety Specialist General Industries 1910 * (RCRA) Resource Conservation Recovery Act of 1976 * Risk management/Safety * Smoke School Certified (Visual Emission Evaluator) * Hazardous Materials * Water Pollution * Air Pollution * Noise Pollution * Warehouse/Inventories * Environment ISO 14001 (EMS) Management System * American Red Cross "Adult First Aid*CPR/AED * ...

Tags for this Online Resume: Occupational Safety and Health Act, OSHA, Compensation, ISO, Licensing, Manufacturing, OSHA Regulations, Scheduling, Training, Physical Security, project engineer

Life Scientist - 20 Years of Experience - Near 30523

QA Manufacturing Compliance Lead Lead QA Validation Remediation - Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products. Conduct review of CMO validation change control and QC OOS/OOT reports and write annual Product Review for all produ...

Tags for this Online Resume: Training, Project Management, Distribution, Management, Risk Management, CFR Part 11, Design Specification, pharmaceutical, protocol, Leadership, Staff development, cleaning validation, process validation, computerized systems validation, Program Management, QC testing, Chemist, CAPA, NCR, Customer Complaints, Supplier Quality, commissioning, equipment qualification, equipment purchase, Change control, Auditing, Medical Devices class I, II and III, Pharmaceutical development DOE, Pharmaceutical Clinical Scale-up, Mfg./Pkg. Management, ISO13485, Technical Reporting, FDA site QA contact