Quality Assurance Manager Resume

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)