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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
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 HVTNs 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.
Under the direction of the HVTN Associate Director for Laboratory Operations and the HVTN QA/QC Project Manager, the QA/QC (Quality Assurance & Quality Control) Associate 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 Good Clinical Laboratory Practices (GCLP) standards.
Coordinate with the laboratory manager and related stakeholders to describe or determine the scope, objective(s), and scheduling of internal and external (e.g., study sponsor) audits.
Perform periodic internal audits
Formally document audit findings and report to HVTN Laboratory Program Director.
Facilitate compliance issue resolutions and incident management with laboratory managers and staff, as appropriate. Provide recommendations, communicate status of action resolution, and bring to management issues that require attention; track corrective actions for effectiveness.
Maintain electronic QA systems (e.g. document control).
Audit final 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 GCLP principles.
Assess clarity, adequacy, and GCLP-compliance of new and revised SOPs. Maintain document control and historical archive of SOPs.
Obtain documented commitments for corrective actions and associated follow up to verify implementation of any such measures.
Facilitate internal and external proficiency/quality assurance testing/evaluation.
Host external regulatory inspections and audits.
In addition, the QA/QC Associate will work collaboratively with 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:
Collaborate in the development, implementation, control and distribution of Standard Operating Procedures (SOPs).
Support of quality assessment and improvement activities for the Network; provide consultative services as appropriate.
BS 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 studies
Experience working in a GCLP, GLP and/or GMP regulated setting
Familiarity with cellular immune monitoring techniques preferred
Experience in immune monitoring of vaccine clinical trials or vaccine development preferred.
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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.