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Online Resumes with "FDA"
Biostatatician
SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guida...
Tags for this Online Resume: Training, Cardiovascular, CT, Documentation, Imaging, Magnetic Resonance Imaging (MRI), Management, Medical
Registered Nurse - 20 Years of Experience - Near 07032
Professional Summary To obtain a position utilizing 33 years of nursing experience. Encompassing 15 years critical care involvement including patient care, management on the director level and 18 years in the field of cardiology, electrophysiology and research. Coordinated research studies working side by side with Investigators, handling all patient and protocol management. Publishing many abstracts and presenting results ...
Tags for this Online Resume: Critical Care, CCU, ICU, Management, Cardiac Services, Cardiology, CATHETERIZATIONS, Insurance
Production Supervisor - 18 Years of Experience - Near 90041
Summary Qualified manufacturing supervisor with 10 years production experience, professionally skilled in leading high productive team, using lean manufacturing principles to reduce cost and increase process efficiency. In-depth knowledge of cGMP regulation and FDA compliance. Dedicated leader with demonstrated ability to train, manage and motivate team members to achieve organization goals and objective. Accomplishments Pl...
Ideal Companies: A growing or prominent biopharmacuetical company. Gilead, Amgen, Roche, Kite, Novartis
Tags for this Online Resume: Management, Quality, Quality Assurance, Quality Control, Inventory, Manufacturing, Corrective Actions, Lean Manufacturing, Production Planing, ISO 8 environment, Chaired Daily QIT meetings
Supply Chain Manager - 15 Years of Experience - Near 32544
Tags for this Online Resume: Drafting, Inventory, Inventory Control, Logistics, Quality Assurance, Test, CMOS, Fabrication
Sr. Program Manager - 15 Years of Experience - Boston, MA
CAREER SUMMARY: A performance oriented Senior Level Manager with 15+ years' experience, offering a unique balance of technology skills, business acumen, leadership and personnel management. Proven track record for defining, building and optimizing best-in-class IT infrastructure, data center operations and customer support technologies and processes. Demonstrated history of team building and gaining the most from IT resourc...
Tags for this Online Resume: Infrastructure, Leadership, Financial, Vendor Management, Program Manager, Compliance, Risk Management, Information Security
Chemist - 15 Years of Experience - Near 07747
SUMMARY OF FUNCTIONAL EXPERIENCE AT AKORN: Hands-on experience with pharmaceutical analysis using HPLC, GC/HS, Spectroscopy, physical and wet chemistry. Familiarity with Analytical Chromatography software Backman Peak-Pro, Perkin Elmer TotalChrom and recently implemented Thermo Fisher Chromeleon. Trackwise software for OOS, OOT and deviation investigation. iStability software for stability monitoring and trending. * Quality...
Tags for this Online Resume: Pharmaceutical, Pharmaceutical Industry, Quality Control Chemistry, Quality Control Chemistry, Quality Control, Accredited Pension Representative, Audit, QC Manager
Clinical Research - 14 Years of Experience
ACCOMPLISHMENTS ACROSS THE CAREER * Successfully manage global CRO within a short span time - turn around trial performance. * Achieved 50% surge in recruitment and ensured recruitment rate for 20+ months by turning around in a challenging trial in an oncology area. * Implemented recruitment strategy in an on-going trial that resulted in 100% achievement to planned patient recruitment in a rheumatology indication. * Bagged ...
Tags for this Online Resume: Management, Planning, Project Management, Project Manager, Proposal Development, Quality, Quality Assurance, Test
Senior Level Biotech & Pharmaceutical Experience
To use my strong Research and Development, QC and QA background in a Qualilty Assurance or Regulatory environment.
Tags for this Online Resume: Assay development, FDA submission
Medical Office Manager - 1 Years of Experience - Near 02120
Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...
Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device
Supply Chain Manager - 15 Years of Experience - Near 28601
SUMMARY War ehouse Oper ations/Shipping & Receiving/Inventor y Management Focused Oper ations Leader with over five years' experience supervising, training, and motivating warehouse personnel to "Do It Right the First Time" on all functions (e.g. shipping & receiving, returns, inventory count and stocking) within a distribution facility. Reputation for identifying, researching, and resolving quality issues within critical t...
Tags for this Online Resume: Quality, SAP, Training, Compliance, Distribution, Management, Medical, Medical Devices
Senior Sales Manager - 10 years Experience - Jefferson City, MO
Summary of Qualifications Accomplished service in business marketing and management with a solid track record of coordinating and driving improved sales, business revenue, and quality by successfully implementing projects through expertise in the following areas: Team Leadership Budget Control Sales Consulting Client Management Process Improvement Mentoring Business Analysis Conflict Management * Strong decision-maker skill...
Tags for this Online Resume: Sales Management, Process Improvement, Client Management, Budget Control, Team Leadership, Consulting, Ordering, Inventory Management, Jefferson City, Columbia
R&D Biomedical Engineer - 2 years of experience - Burlington NC
I'm a Biomedical Engineer with a few years of experience in research and development with experience with the entire development process from needs assessment through FDA regulations and patenting. I have extensive computer, manufacturing and fabrication skills and have a certification of engineering intern on my way to Professional Engineer certification.
Tags for this Online Resume: Research and Development , Biomedical Engineer, Research, Entry Level , Biomaterials, Engineer
