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Please note that this is a not a Job Board - We are an I.T Staffing Company and we provide candidates on a Contract basis. If you need I.T.Professionals to fill a Contract Position, please call (800) 693-8939 or Submit a Request

Qualifications

  • Experienced in cGMP guidelines and USP testing
  • Performed all aspects of stability testing in accordance with ICH guidelines
  • Experienced in raw material handling and release testing
  • Executed in-process and finished product testing and release
  • Proficient in creating standard operating procedures, material specifications and safety guidelines
  • Well adapted in filing deviations, completing CAPA's and investigating "out of specification" results
  • Experienced with culture techniques, virology, aseptic processing, sterile manufacturing

Work Experience

10/2010- Present: Confidential
Quality Control\\Quality Assurance Manager

  • Support Phase I and II clinical trials in HIV and Cancer using Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)
  • Responsible for carrying out Cellular Immunology experiments and tissue culture with T cells, Mesenchymal Stromal cells, Dendritic cells, and HIV-infected cells in support of early phase cell and gene therapy clinical trials
  • Quality Control Assays for release of all cellular products under specified qualifications within the facility such as: Flow Cytometry, Endotoxin, and Mycoplasma
  • Recommend corrective action to compliance issues and/or observations as needed to ensure corrective actions are developed to address the issue(s) or root cause

12/2008- 10/2010: Confidential
Clinical Research Associate\\Regulatory Specialist

  • Supervised data management and submission of protocol related documents to various committees for review and approval, as well as maintenance of regulatory documents for assigned studies
  • Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas
  • Managed the progress of assigned studies by tracking IRB and FDA regulatory submissions
  • Coordinated the conduct of study related activities for several clinical trials

11/1999 - 11/2008: Confidential
Marketing Manager

  • Negotiated tour and venue sponsorships
  • Developed overall budget and promotional plan for department
  • Created the company\'s first charitable donation marketing program, raising over $65k for school supplies
  • Helped organize 3rd party collaborations to improve sales and decrease expense of sponsorships
  • Managed and directed 120 events planning staff

Education

M.S.O.D, Organizational Dynamics

  • Organizational Leadership Studies and Organization Development and Change Studies Certificates/Concentrations
  • Program/Project Management Skills and Systems

B.S, Biology

Awards

  • 2010 C.A.R.E Award Recipient - The Clinical Research Coordinator Annual Recognition of Excellence award from the University of Pennsylvania School of Medicine
  • Two-time TransWorld Manager of the Year Pinnacle Award 2005 and 2007
  • Certified Clinical Research Coordinator (CRC)
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Certifications

Hire IT People, LLC is a Certified Business Enterprise by the Department of Local and Small Business Development, Washington DC and a Preferred IT Staffing Vendor under the ITSA Program, a Supplier to Various State Agencies and Fortune 500 Clients.