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Online Resumes with "FDA"
Chemist - 15 plus Years of Experience
SUMMARY An analytical scientist with 10 plus years in the pharmaceutical research and testing industry. Have supervised up to seven people and trained new and experienced scientist. Been responsible for the generation and review of data, reports and the release of reports. Oversaw the inventory of controlled substances for the departments and interacted with the DEA and FDA for inspections and audits.
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Research, Good Laboratory Practices, Good Manufacturing Practices, Analytical Chemist
Manufacturing Baker - 20 Years of Experience - Near 07856
PROFILE Over thirty years of experience in the Pharmaceutical Contract Packaging Industry with responsibilities for the day to day operations of production equipment, with the emphasis on safety. Quality and cost labor utilization, knowledge of the regulatory requirements of FDA, cGMP's. Effective interpersonal and influence management skills, interacting with cross- functional teams. A well respected team leader who can qu...
Tags for this Online Resume: Pharmaceutical, Packaging, Switches, Manufacturing, Inventory, Management, Quality, Quality Assurance, maintenance, manufacturing, production
Microbiologist - 15 Years of Experience - Near 80422
Versatile and highly competent quality management executive offering 15 years of experience working in the pharmaceutical industry. Expertise in quality assurance, quality control, and handling production personnel & customers, with a proven record of consistently achieving and exceeding objectives. Efficiency in coordinating compliance and operations to ensure products meet required specifications under FDA, EU and other ...
Tags for this Online Resume: quality assurance, validation, microbiologist, compliance specialist, pharmaceutical, medical devices, quality systems development, total quality management, Management, Microbiology
Director - 23 Years of Experience - Near 28079
Summary Ambitious Sr. Manager with more than 23 years of management experience in Manufacturing/Distribution/Logistics/Repair & Refurbishment environments. Applies strong analytical and critical thinking skills to solve complex operational problems. Ability to direct complex projects from concept to fully operational status, goal-oriented individual with strong leadership capabilities and a passion to succeed. Ability to st...
Tags for this Online Resume: Distribution, Process Improvements, Logistics, P&L, Configuration Management, Configure, IBM, Management, Services, Telecommunications
Clinical Research - 1 Years of Experience - Near 10710
Areas of Expertise * Direct patient contact * SOPs Implementation * FDA regulatory knowledge * Clinical Trials * Managerial
Tags for this Online Resume: Psychiatry, Data Management, Management, Accounting, Audit, Clinical Research, Data Entry, Evaluate, Forecast, Hepatitis
Regulatory Affairs and Compliance Expert
Detailed knowledge of substantial body of regulatory information, including but not limited to OHRP, FDA, HIPPA. Management and training of professional staff with leadership abilities that ensure communication and compliance from all entities. Skilled and well educated in performing audits, needs assessments and use of resources and appropriate resource management. Knowledge and experience with clinical, research report...
Ideal Companies: Research Institutions, Clinical Research
Tags for this Online Resume: Management, Policies and Procedures, Protocol, Research, Leadership, Compliance, Assessments, Health Insurance Portability And Accountability Act, Resource Management, Training
Biostatatician
Summary Highly skilled, results-oriented and a loyal Biostatistician with 15+ years of leadership experience. I have played vital roles in clinical development of and launches, or commercial marketing of medications in the realms of Cardiology, Anti-Infectives, Anti-bacterial, Ophthalmology, Immunology, Regenerative Medicine, CNS, Hematology and GHD. Phase 2B/3/4 clinical trials in varied therapeutic areas. Statistical lead...
Tags for this Online Resume: Documentation, Medical, Medical Affairs, Publications, Due Diligence, Outsourcing, Pharmaceutical Industry, Process Improvement, Product Development, Protocol
Quality Engineer - 19 Years of Experience - Near 92555
Professional Summary: Goal-driven Senior Production & Quality Manager with broad experience in fast-paced, high-tech environments requiring expertise in production scheduling, quality management, Project Management, training, cost control and Continuous Improvement Programs. Thoroughly familiar with a broad range of manufacturing protocols, including SMT, KANBAN, CONWIP, QRM, JIT, SPC, TQM, 5S, DFM, DMAIC, Kaizen, QFD, SMED...
Tags for this Online Resume: Inventory, SPC, Process Improvement, Product Launch, 5S, Audit, Clubs, Corrective Actions, Integrate, Inventory Control
Biochemist - 19 Years of Experience - Near 53719
SUMMARY Over 35 years of cumulative global molecular research experience with an in-depth knowledge of genetic engineering, transformation, cell-culture and aseptic techniques. Well recognized in the areas of research and product development, project management and technical support in pharmaceutical and biotech industries. Ten years of experience working with United States Pharmacopeia (USP) as Expert Committee Ad Hoc Advi...
Tags for this Online Resume: Propagation, Protocol, API, Laboratory Work, Publishing, Data Management, Management, Procurement, Research, Training
Quality Coordinator - 5 Years of Experience - Near 08817
PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...
Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting
Biochemist - 20 Years of Experience - Near 53719
SUMMARY Over 35 years of cumulative global molecular research experience with an in-depth knowledge of genetic engineering, transformation, cell-culture and aseptic techniques. Well recognized in the areas of research and product development, project management and technical support in pharmaceutical and biotech industries. Ten years of experience working with United States Pharmacopeia (USP) as Expert Committee Ad Hoc Advi...
Tags for this Online Resume: Propagation, Protocol, Publishing, API, Laboratory Work, Data Management, Management, Procurement, Research, Training
Marketing - 19 Years of Experience - Near 19382
Accomplishments * Improved profitability and secured a $300K savings by reducing production costs and monitoring marketing expenses through working with account management team and varied other partnerships, facilitated the onboarding of a new major Philadelphia Health System account and assisted in subsequent strategic planning and implementation * Onboarded a new pharma client while growing and maintaining position in "to...
Tags for this Online Resume: Social Media, Management, Networking, Client Communications, Communications, Content Management, Marketing Management, Sales, Sales Executive, Account Management, Customer success, client engagement
