CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA"

Operations Manager

SUMMARY OF QUALIFACTIONS * Strong understanding managing Plant Operations including: Planning, Scheduling, Training. * Extensive food industry Production Management experience working with Maintenance, Quality Assurance, Shipping & Receiving, Human Resources, and Safety Managers. * Strong understanding of measures to control product costs, labor, and yields. * Ability to implement production systems, define continuous impro...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Distribution, Purchasing, Planning, Layout, Packaging, Management, Food Service

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

Biochemist - 15 Years of Experience - Near 92129

SUMMARY Research and development scientist with a broad technical expertise in microbiology and molecular biology in the Biotechnology and Pharmaceutical industry Multiple years of bench/hands-on extensive experience in microbiology and molecular biology for in vitro diagnostics assays (IVD) development for infectious diseases, food borne pathogen detection, genetic markers in field of oncology. Performed classic and molecu...

Tags for this Online Resume: Research, Atlas, Automation, Integrate, Microbiological Testing, Protocol, Test, Cancer, Diagnostics, Documentation

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

Quality Manager - 19 Years of Experience - Near 34771

Profile A self-motivated and organized professional with over nineteen years' experience in FDA regulated pharmaceutical, biotechnology, and medical device industries.

Tags for this Online Resume: Consulting, Pharmaceutical, Microbiology, Assessments, Attention to Detail, Bilingual, Biotechnology, Corrective Actions, manufacturing, production, "project management", reliability, investigation, validation, cleaning, ISO, cleanroom

Biomedical Engineer - 16 Years of Experience - Near 55127

Tags for this Online Resume: Labview, Technical presentation, Sensory psychophysics, Graphical display of data, Laboratory design, Robotics engineering, FDA interactions, Cross functional collaborations, Mentoring, research, clinical

Facilities Manager - 17 Years of Experience - Near 18017

Summary: Management Administration * Analyze annual needs, create forecasts, and set quotas * Perform financial analysis on capital purchases * Fleet and Facility Management * Recruit, hire, and train new personnel * Budget administration, inventory control, and purchasing of supplies * Maintain positive customer and vendor relations * Maintain quality practices while assuring conformance of all activity with company, AABB,...

Tags for this Online Resume: Project Management, Project Manager, Pricing, Distribution, Inventory, Satellite, Advertising, Budgeting, Communication Skills, Financial, building maintenance

Programmer Analyst - 10 Years of Experience - Near 21044

SUMMARY * Certified Clinical SAS Programmer with years of experience in SAS Base/Advance with extensive knowledge in drug development process and clinical trials. * Extensively working on various therapeutic areas like Oncology, Dermatology, InfectiouDiseases, Respiratory, Copd, Immunology, Cardiovascular and Nuerology. * Extensively working on clinical trial projects (Phase I, II and III) with Bio-Statisticians, Data manag...

Tags for this Online Resume: Statistical Analysis, HyperText Markup Language, Proc, VITAL SIGNS, SAS, Macro (Predefined Code), Oracle, Oracle Clinical, PDF, Protocol, sql, html

Medical or Health Services Manager

Areas of Expertise * Acute Care Facility & Ambulatory Care Experience * Radiation Oncology & Medical Oncology * Utilization Management-Inpatient & Outpatient Review * Transplantation & Genetic/Molecular Marker Testing * Clinical Research via National Clinical Trials * McKesson, Interqual, NCCN, ASCO, & CMS National Guidelines FDA Approval * Guidelines and policies written and maintained * Multi-tasking in fast-paced environ...

Tags for this Online Resume: Oncology, Radiation, Acute Care, Ambulatory Services, ARIA, Biopsy, Brachytherapy, Chemotherapy, Clinical Research, Cms

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

Department Manager - 13 Years of Experience - Near 68135

Executive MBA with a doctorate in Chemical Engineering with over 16 years of experience in the development and management of pharmaceutical operations. Expertise in creating operating processes, protocols, policies and technologies to support new drug manufacturing and marketing on a global scale. Proven record in DEA compliance. Outstanding leader with demonstrated abilities in transforming under performing teams into high...

Tags for this Online Resume: Manufacturing, Troubleshooting, Accounting, API, Application Program Interface, Management, Pharmaceutical, Services, Utilities, Automation, steel, "project management"

Datawarehouse Designer - 11 Years of Experience - Near 28262

SUMMARY * ORACLE certified professional with 12+ years of hands-on experience in Oracle PL/SQL, DataModeling, Datawarehouse, ETL-Design, InformaticaPowerCenter9.x, SSIS, SSRS and Oracle Forms & Reports. * Strong Customer interaction skills and excellent expertise in Requirements gathering, Analysis, Estimation and Resource Planning. * Pretty good exposure in database design and extensive hands-on in handling ORACLE packages...

Tags for this Online Resume: Oracle, Database, Database Performance Tuning, Performance Tuning, Utilities, Business Analysis, Business Analyst, ETL, Extract Transform Load Tools, Shell Script, sql