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Online Resumes with "cfr"



Quality Assurance Director - 20 Years of Experience - Near 92336

A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...

Tags for this Online Resume: Documentation, Management, Project Management, Pharmaceutical, documentation control, documentation management, quality systems

Quality Manager - 1 Years of Experience - Near 23703

PROFESSIONAL SUMMARY: Intelligent, self-motivated, well organized individual with an excess of 12+ years of experience in government and industrial Quality Assurance along with safety and Operational Risk Management. Expertise in industrial and economical safety/testing and mechanical repair as per the U.S. Navy and Assembly Line Team Leader for Ford Motor Company. Relevant skills include: * AS/BS Electronics Engineering * ...

Tags for this Online Resume: Engineering, Information Technology, Professional Services, Services, Abf, Valves, Assembly Line, Audit, Communication Skills, Complaints

Quality Manager - 20 Years of Experience - Near 92688

Certified Quality Assurance Director with a successful 27 year career in a leading Aerospace, Aviation and Defense industry. Extremely resourceful and self-starter individual with strong analytical, technical and engineering expertise with critical structural and avionics aircraft component design and manufacturing, combined with a wide knowledge of Quality System regulations and QMS implementation support to ISO-9001-2008,...

Tags for this Online Resume: Certified Six Sigma Green belt, Process Improvement, PPAP, SPC, RCCA, CAPA, Project Management, Strategic Planning, Quality Assurance, Test, manufacturing, mechanical engineer, "project management", reliability

validation/quality/manufacturing engineer

PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...

Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing

Construction manager - 20 Years of Experience - Near 82930

SUMMARY OF QUALIFICATIONS TOP SECRET SECURITY CLEARANCE, 30 years of experience in industrial, commercial and residential construction projects, including new construction, retrofits, modernization, and resident improvements on projects with the US Department of State, US Navy, US Army Corps of Engineers, and various private entities. Project Management Certifications from Villanova University NCCER Certified Plus!(TM): Car...

Tags for this Online Resume: Compliance, Corrective Actions, Management, Architectural, Security, Carpenter, Documentation, Drywall, Physical Security, SRC

Clinical Quality Assurance - 13 Years of Experience - Near 92057

QUALIFICATIONS: Over 13 years of experience in the Pharmaceutical and Medical Device Industry. I have a proven desire to enhance team effort and first time quality concepts, Strong creative research skills, Strong detailed and task oriented skills. Work environment regulated by 21 CFR 820 and ISO 13485:2003 & 9001. Specialized in Quality Assurance, Regulatory Compliance, GMP, Document Control, QSR training, Excel, Power Poi...

Tags for this Online Resume: Compliance, Accounts Receivable, Customer Service, Inventory, ANSI, Ansi (Am Natl Stds Inst), Training, Audit, Document Control, ISO

Project Manager

Tags for this Online Resume: Management, Project Management, Project Manager, Legacy, Manufacturing, Automation, CFR Part 11, Compliance, Documentation, Health Insurance Portability And Accountability Act

Featured Profile

Transportation manager - 18 Years of Experience - Near 45241

18 years of management experience at UPS as Senior Lead Operations Supervisor. Operational lead for 2 of the largest logistics operations in Fortune 25 company's largest district. Large number of union, non-union and supervisory direct reports. Interested in continuing with a dynamic and growing, team oriented firm and sharing my decades of experience.

Tags for this Online Resume: Team Lead, Customer Service, Sales, management, manager, assistant manager, Idustrial Engineering, Conflict Resolution, Microsoft Office, Microsoft Excel, Powerpoint, Java, Dispatching, Staffing

Director of Quality

Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12 of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, project-management and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, supplier management and all aspects...

Tags for this Online Resume: R&R Report Writer, Automotive, Management, Quality, Quality Assurance, Quality Management, ISO, ISO 9001, Documentation, Project Management

Statistical Programmer - 5 years Experience - US

Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...

Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test

Microbiologist

A Validation Engineer with proven success working with major pharmaceutical companies and diversified experience across all aspects of the industry: Quality control manufacturing regulatory compliance and multiple departmental operations. Consistently demonstrating a high level of experience in all aspects of the development execution and close out of commissioning/qualification programs using process design documentation p...

Tags for this Online Resume: Manufacturing, Assessments, Automation, Utilities, Microbiology, Protocol, Collection, Documentation, High Performance Liquid Chromatography (HPLC), Marketing Management

Clinical Research - 6 Years of Experience - Near 80918

Pursuing a challenging career in an organization where I can apply my talents and education in a medical/scientific-related field. Qualification Highlights Proficient use of Databases: iMedidata RAVE, RTOG, GOG, Inform, Oncore, CTSU, SWOG, Clincapture. Oversee RNs are strictly following X-Chart requirements of study protocols. Reviews Expectancy Reports of all associates in our department to ensure data timelines are met. R...

Tags for this Online Resume: Clinical Research, Research