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The Long and Winding Road: Duties of an NHEERL QA Manager from 1999 to 2008
HUGHES, T. J. The Long and Winding Road: Duties of an NHEERL QA Manager from 1999 to 2008. Presented at EPA Quality Management Meeting, San Antonio, TX, May 12 - 14, 2009.
This abstract discusses the duties and responsibilities of a QA Manager at NHEERL from 1999 to 2008.
My career as a US EPA Quality Assurance Manager (QAM) started on September 26, 1999 when I was appointed the QA and Records Manager for the Experimental Toxicology Division (ETD) in NHEERL, in the Office of Research and Development (ORD), on the Research Triangle Campus in RTP, NC. I was responsible for the training and QA and records oversight of approximately 100 scientists, which included EPA researchers, PostDocs and technical senior environmental grantees (SEEs). These scientists had 25 active research projects and 300 operating procedures (OPs) in place. At that time, each of the principal investigators (PIs) in the division had one-three laboratory scientists conducting research. In 2008, ETD has 65 active research projects and 520 OPs. Many of these projects are multilab and multiagency projects. Twenty of these projects are QA Category 1 and 2 studies which require intensive QA oversight and audits. The positive support my division director, Dr. Linda Birnbaum, along with the cooperation and assistance from the NHEERL Director of QA, Brenda Culpepper; have allowed me to build a very strong QA and records program in ETD. The organization of the ETD QA Core Team, annual QA and records seminars, annual PI surveillances and monthly newsletter articles on QA and records issues have been the tools that were used to build a defensible and accurate research database in ETD. The scope and the depth of the QA and records program in ETD have grown exponentially in the last nine years, especially for electronic records. Over the past five years, research dollars in ETD have decreased significantly, but QA requirements (ORD PPM 13.2 and 13.4) and oversight also have increased significantly. Less money at the USEPA has caused projects to increase in size and in numbers of participants (synergy), both within and outside the Agency. The responsibilities for the QAM have increased, especially for multilab and multiagency projects (i.e., Project QAM [PQAM] duties). The evolution of my QAM duties and responsibilities over the last nine years will be discussed. The days of the one PI with their one-two intramural research projects are vanishing! This is an abstract for presentation which has been reviewed by the U.S. EPA; views expressed do not necessarily represent EPA policy.
Record Details:Record Type: DOCUMENT (PRESENTATION/ABSTRACT)
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LABORATORY
EXPERIMENTAL TOXICOLOGY DIVISION