The HIV Vaccine Trials Network (HVTN) Laboratory Program is part of an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses to testing vaccine efficacy. The Laboratory Program is responsible for carrying out the scientific agenda of the HVTN in determining by laboratory based studies which vaccine regimens should be advanced for efficacy trials and show promise for licensure. This effort includes leading a number of working groups, committees, specimen repository oversight, assay performance and quality assurance.Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.Under the direction of the HVTN Associate Director for Laboratory Operations, the QA/QC (Quality Assurance & Quality Control) manager will be responsible for participating in the development, implementation and maintenance of quality assurance systems and activities related to all aspects the Seattle HVTN Immunological Endpoint Assay and Specimen Processing Laboratories. This will include but is not limited to the duties described below.Conduct laboratory audits and informal inspections to ascertain that all activities conform to GCLP standards.Coordinate with the laboratory manager the scope, objective, and scheduling of audits.Formally document findings and report to HVTN Laboratory Program Director.Facilitate compliance issue resolutions with laboratory personnel. Provide recommendations, communicate status of action resolution, and bring to management issues that require attention; track corrective actions.Maintain QA database.Audit study reports to ascertain that the report reflects the raw data of the study.Monitor and maintain archives of pertinent documents for their adherence to GLP principles.Assess clarity and GLP compliance of new and revised SOPs. Maintain document control and historical archive of SOPs.Obtain commitments for corrective actions and follow up to verify implementation of any such measures.Facilitate internal proficiency testing.Host external regulatory inspections and audits.In addition, the QA/QC manager will lead the central HVTN Quality Assurance Program. This includes interacting with QA mangers at network laboratories to help ensure compliance with HVTN procedures and DAIDS GCLP guidelines. Central QA activities will include but are not limited to:Assist network laboratories in preparing for auditsReview audit reports for network laboratories and assist in resolution of findingsReview plans and provide consultation for validation of assaysEnsure compliance with GCLP guidelines in all HVTN- affiliated laboratories.Assist in the coordination and standardization of laboratory procedures utilized in HIV vaccine clinical trials.Development, implementation, control and distribution of Standard Operating Procedures (SOPs).Support of quality assessment and improvement activities for the Network.Training and evaluation of proficiency of laboratory personnelReview of study plans and study reports for all HVTN protocol assaysBS or MS degree in an appropriate scientific field.Membership/certification in SQA (Society for Quality Assurance) strongly preferred.Familiarity with regulatory requirements for laboratory-based immunogenicity studiesExperience working in a GLP and/or GMP regulated settingFamiliarity with cellular immune monitoring techniques preferredExperience in immune monitoring of vaccine clinical trials or vaccine development preferred.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before ...that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.