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Project Manager Resume Example

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PROJECT MANAGER
Professional Overview
Quality Assurance Associate -- Medical Devices & Diagnostics Core Qualifications State & FDA Audits & Inspection Critical Thinking Assessing Performance Time Management Process Improvement Cross Functional Team Leadership Statistics/Trending SOP Development & Implementation
Core Qualifications
Complex Problem Solving Monitoring/Assessing Performance Organization Time Management Multi-tasking Excellent Written & Communication Social Perceptiveness Mathematics
Education
Master of Science: Biomedical Sciences2005St. George's UniversityBay Shore, NY, USMaster of Science: Biomedical Sciences 2005 St. George's University Bay Shore, NY
B.S: Biological Sciences2000Cornell UniversityIthaca, NY, USB.S: Biological Sciences 2000 Cornell University Ithaca, NY
Experience
Project Manager09/2012 to CurrentCustom Awning & CanvasSan Diego, CAIncreased regional sales 27% annually Implemented technical drawing with AutoCAD for efficiency & reproducibility Graphic renderings with Awning Composer enable customers to visualize product Established website to generate customer leads Improved turnaround time by creating database of 30 years past estimates, work orders, and invoices
meetings and assist in processing Non-Conforming Material02/2008 to 05/2011Document ControlSan Diego, CAInvivoscribe Technologies, Inc San Diego, CA Document Control in compliance with 21 CFR Part II 820.40 Review & approve manufacturing batch records; identify & execute Quality Management System improvements Participate in the Material Review Board (MRB) meetings and assist in processing Non-Conforming Material Reports (NCMR) Responsible for calibration & equipment maintenance programs; write SOPs & train personnel Track, monitor, and schedule equipment calibration and repair; review calibration certificates Scan, file, and archive manufacturing batch records Assist QA Manager with supplier qualification, internal/external audits, and management review ERP fluency; master-level proficiency MS Word/Excel/Access
Physician/Surgical Assistant02/2006 to 08/2006La Jolla Center for Facial Plastic SurgeyLa Jolla, CAEstablished new surgical suite compliant with OSHA guidelines Customer service, ordering/inventory supplies Patient care pre & post-op Prepare operating room for surgery, setup surgical instruments & equipment in sterile conditions Assist surgeon by sponging, suctioning, holding retractors, stemming bleeding & suturing Monitor/track equipment during surgery
Research Associate I07/2001 to 08/2003Lion Bioscience AGLa Jolla, CADeveloped in silica physiologic model to predicts ADMET (absorption, distribution, metabolism, elimination, and toxicology) of small molecule drugs in human & rat Extract pharmacokinetic data from scientific journals in effort to simulate virtual drug disposition Input pharmacokinetic parameters (bioavailability, molecular weight, structure, solubility) into differential equation & examine output Validate output & present finding to department heads Co-leader of Drug Distribution team; aim to predict dispersion /compartmentalization of small molecule drugs in fluids & tissues of body Accomplishments Medical Device & Diagnostic License granted to Invivoscribe Technologies 2009 Successful Lion Kinetica v3.0 software validation findings ensuring departmental funding for Computational PK during Lion/Trega merger
Memberships/Scholarly Societies
CPR & AED Certified (American Heart Association)
Certifications
CPR American Heart Association ISO13485 ISO 9001 Quality Management System & ISO 19011 Internal and External Audit Training GCP Training International Device Trials Conference - Conducting Clinical Trials in the Developing World (Strategies to Maintain Compliance) OSHA blood-borne pathogen certified Trauma Evaluation and Management certified (American College of Surgeons) Memberships/Scholarly Societies SDRAN (San Diego Regulatory Affairs Network) Torrey Pines Gulls Soaring Society
Skills
Access, Audits, Batch Records, Calibration, Employee Resource Group, Enterprise Resource Planning, Equipment Calibration, Equipment Maintenance, Erp, Excel, File, Maintenance, Ms Word, Non-conforming, Qa, Quality Assurance, Sops, Word, Autocad, Database, Invoices, Leads, Project Manager, Regional Sales, Sales, Absorption, Associate, Medical Device, Metabolism, Pharmacokinetic, Software Validation, Toxicology, Customer Service, Inventory, Ordering, Receptionist, Retail Sales, Sterile, Audit, Clinical Trials, Cpr, Excellent Written, Fda, Gcp, Inspection, Iso, Mathematics, Medical Devices, Problem Solving, Process Improvement, Regulatory Affairs, San, Sop, Statistics, Storage Area Network, Time Management, Training, Biomedical, Biological Sciences
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Resume Overview

Companies Worked For:

  • Custom Awning & Canvas
  • Document Control
  • La Jolla Center for Facial Plastic Surgey
  • Lion Bioscience AG

School Attended

  • St. George's University
  • Cornell University

Job Titles Held:

  • Project Manager
  • meetings and assist in processing Non-Conforming Material
  • Physician/Surgical Assistant
  • Research Associate I

Degrees

  • Master of Science : Biomedical Sciences 2005
    B.S : Biological Sciences 2000

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