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Online Resumes with "FDA Compliance"
Summary of Qualifications Experienced and highly qualified Scientist & Research Associate/Manager with over 20 years of experience in researching and teaching. Highly proficient in performing quality assurance control on laboratory best practices while leveraging R&D experience to consistently achieve project goals. Adept at supervising other scientists and research technicians in advancing stem and primary cell industry kn...
producer Directed the Open Text professional services group to effectively install, customize, and implement SAP Archiving and Document/Data Access solutions. Met or exceeded group's revenue and margin targets and customer service expectations. Won major competitive accounts through pre-sales activities. Managed $1M budget and 10 consultant direct reports along with subcontracted SAP and Open Text professionals. * Teamed wi...
HIGHLIGHTS OF QUALIFICATIONS * Providing Key Project Management (PMP) as well as hands on experience in the Acquisitions and Mergers of business technology and business practices into new business platforms. This would be the integrating old business legacy systems with new technology or integration into new owner systems and software. Mergers with Airline, Banking and Automotive companies. * Senior management consultant wi...
Tags for this Online Resume: Security, Cellular, Software, Software Development, Strategic Initiatives, ACD, Vignette, Adobe, Automatic Call Distribution, e-Commerce, it jobs, agile, software, sql, Senior Program / Project Manager, M&A Consultant
SUMMARY Strategic Leader with expertise in creating high performing teams in Engineering, Maintenance, Reliability, Operations, and Facilities. Proven successes in knowledge transfer, process mapping, configuration management and improving quality in fast-paced environments. Technically driven with engineering background and strong track record in setting and meeting metrics and accountability in the avionics, cryogenics, D...
Tags for this Online Resume: Project Management, Project Manager, Purchasing, Quality, Quality Assurance, Distribution, HVAC, Insulin, Manufacturing, Reliability, Maintenance, Smelting, Utilities, Medical Devices, Planning and Scheduling, Change Management, DoD, Pharma, Fermentation, High Purity Water, Maintenance Management, GMP, Lean Manufacturing, Six Sigma Green Belt, Environmental, Health and Safety, Knowledge Transfer
SUMMARY OF EXPERIENCE Experience in clinical trial coordination, including initiating, administering and maintaining protocols with emphasis on FDA compliance. Therapeutic areas of experience include Cardiology (Hypertension), Infectious Disease (Prostatitis and UTI), Diabetes, Obesity, Respiratory, Nephritis, Irritable Bowel Syndrome, COPD, GERD and Pain Management (Osteo-Arthritis). Phases include II, III and IV.
Tags for this Online Resume: Clinical Research, Research, Documentation, Protocol, Billing, Chiropractic, Document Review, Filing, Health Insurance, Insurance, clinical, trial, protocol, pharmaceutical, phase, oncology, gcp
SUMMARY OF QUALIFICATIONS 21 years hands on experience in the Medical Device industry dealing with ISO, MDD & FDA compliance. 11 years regulatory affairs experience.
Profile: Experienced Analytical Chemist * Self-motivated, result driven, detail oriented individual, works well as a team member or independently, willingness to learn * Strong background in GMP/GLP, analytical and wet chemistry * Well-versed in USP, EP and JP policies and procedures, chemical hygiene and safety policies * Analysis and release of raw materials, finished products, in process, and stability samples * Method d...
Tags for this Online Resume: Audit, Documentation, Kaizen, Management, Packaging, Quality, Quality Assurance, Quality Control, EP, pharmaceutical, Quality control, Laboratory, analytical, chemist, GMP
SUMMARY My name is Bill Christian. My entire career has been in Maintenance Engineering with 26 years as either a Plant, Chief or Regional Engineer. Most of my career has been in Alaska where the remoteness translated to a lack of outside contractors. Production was seasonal which required an immediate and accurate response to all situations and emergencies. Listed below are my most recent experiences. I look forward to dis...
Tags for this Online Resume: Budgeting, Cardiopulmonary resuscitation (CPR), CAT, Control Systems, Engineering, Hydraulics, Occupational Safety and Health Act, OSHA, Power (Os Enhancemnt Tool, Root Cause Analysis, maintenance, "project management", production, mechanical engineer, manufacturing
Summary * IT Infrastructure Senior Project Manager, engagement lead, and high-reliability business advisor. Full range of PM tools and methods as warranted by project, client, and business requirements. * Direct management responsibility for multiple pharma and hospitals compliance including: (1) SOX audits to prove IT readiness, performance, record integrity, and reporting: (2) Joint Commission on Hospital Accreditation (J...
Summary Senior Supply Chain, Manufacturing and Operations international executive with diverse industry experience and expertise in building, motivating and leading teams through turnarounds, acquisitions and organic growth with global organizations. Extensive track record in optimizing operating costs, streamlining operations, increasing efficiency, meeting regulatory compliance requirements and transforming business cultu...
Tags for this Online Resume: Documentation, UI Design, Compliance, Process Improvement, SAS, Software, Software Development, Agile, AT&T, Business Analysis, agile, software, Project Management, Scrum Master, SDLC, OMS, WMS, FDA COmpliance
Professional Summary More than 14 years of experience in Pharmaceutical and Life Sciences Industry with key focus in Business Requirements Analysis Data Analysis and Management Software Application Testing Document Management Change Control and Release Management FDA Compliance Verification and Validation Quality Assurance Processes and Methodologies Developing Testing Strategies and Test Plans Test Scenarios and executing ...