CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "validation protocols"

Aerospace Engineer - 10 Years of Experience - Near 92627

SUMMARY OF QUALIFICATIONS * Experienced in validation test practices, test methodologies, hardware design set-up electro/mech. test fixtures, components, software, digital circuits, phases and tools in respect to prototype systems. * Ability to identify critical process parameter, characterized process, and generates the validation protocols and equipment qualification tests. * Ability to set-up and execute any test for EMI...

Tags for this Online Resume: Test, Software, EMC, Radiation, Reliability, sheets, Utilities, Applications, Corrective Actions, Diagnostics, honeywell

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

Clinical Data Management - 5 Years of Experience - Near 56003

SUMMARY * 5.4 years of experience in analyzing and gathering data for Clinical trials. * Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the data-management lifecycle. * Work closely with Oracle Clinical developers on the design, testing and implementation of study databases. * Extensive experience in trial start-up, trial conduct, database lock and Post data...

Tags for this Online Resume: Data Entry, Management, Protocol, Cancer, Immunology, Infectious Diseases, Query, Team Lead, Data Management, Data Manager, oncology, phase, clinical, trial, protocol, gcp, pharmaceutical, ich, OC database, OC-RDC-TAO database

Plant Operator - 20 Years of Experience - Near 01510

SUMMARY Technical leader with extensive experience in an cGMP FDA regulated industrial manufacturing setting. Committed to safe work practices, quality systems, customer service and compliance for the support of operational activities. Proactive, accountable and collaborative team player. Active member of many highly successful cross functional teams. Proven ability to prioritize and coordinate effectively. ACCOMPLISHMENTS ...

Tags for this Online Resume: Documentation, Automation, Compliance, Customer Service, Lean Manufacturing, Management, Manufacturing, Power (Os Enhancemnt Tool, Preventive Maintenance

Biochemist - 18 Years of Experience - Near 44202

Professional Summary I have over ten years of experience in the Biotech industry in both Research and Development and Quality Control). Accomplishments/Skills Technical experiences skills including: * Protein purification using anion exchange, affinity, HIC and SEC as well as HPLC. * Operation of an Agilent and Water's HPLC * Operation of the GE AKTA and Bio-Rad NGC FPLC systems * Cloning and expressing proteins in E. coli....

Tags for this Online Resume: Process Improvement, Troubleshooting, High Performance Liquid Chromatography (HPLC), Quality Control, Research, Manufacturing, Protein Purification, Protein Analysis, ELISA Assay, Western Blot analysis, qPCR/PCR, Cloning, cGMP

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

Program Manager - 0 Years of Experience

Career Summary * Over a decade of experience as a Project Manager, primarily in the medical device industry, and inclusive of the following professional skills: * Project Management and New Product Development * Product Design & Engineering (for manufacturability, DFM) and Engineering Change Control * GMP, Good Manufacturing Practice, and Lean Six Sigma Manufacturing * Process Development and Statistical Process Control * I...

Tags for this Online Resume: Training, Billing, Change Control, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, manager, civil engineering, architecture, construction management

Packaging Engineer/Manager-20+ Years Experience

QUALIFICATIONS Package development professional with notable success in development and launch of new initiatives and substantial cost saving efforts excellent written and oral communication skills ability to work effectively across different functions, and with diverse groups. Skills/experience include: * Develop packages to achieve the intended design, quality, cost objectives, functionality, and manufacturability. This n...

Tags for this Online Resume: Packaging, Manufacturing, Business Development, New Business Development, Packer, Project Management, Project Manager, Retail, SAP MM module, Tooling

Quality Manager - 20 Years of Experience - Near 00727

evaluates Reviews and approves change control validation protocols and reports to all manufacturing processes as blending granulation compressing coating and printing. Maintains documents in an organized and traceable manner. * Provides advice and service to all operating departments as to assure compliance with cGMP's and other regulations. This includes frequent feed back on performance regarding deviations rejections com...

Tags for this Online Resume: Manufacturing, Management, Complaints, Documentation, Pharmaceutical, Quality, Quality Assurance, Test, Packaging, Project Management

Life Scientist - 38 Years of Experience

Develop (Opus Bio Technologies/ QAL.LAB.) Protocol development and execution such as IOQ's assisted in coordination for field work. Prepared final reports, reviewing Kaye print out data qualifications for final reports and signing reviews for reports. Meetings with client to coordinate work schedules. Field execution Autoclaves, PLC's, Tanks lab. Equipments qualification IOQ, PQ, (Incubators, Freezers, Autoclaves, Ovens, Re...

Tags for this Online Resume: HVAC, Utilities, Documentation, High Performance Liquid Chromatography (HPLC), Audit, EDP, Inventory

Chemist

SUMMARY OF QUALIFICATION An accomplished research professional with excellent communication skills who is organized, detail oriented and a team player. Has over 21 years of experience and extensive background that includes leadership role in analytical research in many reputed pharmaceutical organizations. KEY AREA OF EXPERTISE Lead and supervised a team of scientists to execute analytical method development, method validat...

Tags for this Online Resume: DSC, Emerging Markets, High Performance Liquid Chromatography (HPLC), Spectrophotometer, Management, Engineering, Reverse Engineering, Accounting, CFR Part 11, Cost Accounting