QA Associate II

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

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.
The HIV Vaccine Trials Network (HVTN) Laboratory Center is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS and related infectious diseases. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The Laboratory Center is responsible for carrying out the scientific agenda of the HVTN by conducting laboratory based studies to evaluate the immunogenicity of investigational vaccines.

- Manage assigned site labs for HVTN and client protocol preparation; includes provision of site training, ensuring appropriate supplies on site, developing and communicating protocol-related lab practices, determining site equipment needs, and monitoring Good Clinical Laboratory Practice compliance.
- Assist site labs with implementation of their tailored Quality Assurance plans, including but not limited to the writing and use of laboratory SOPs, establishment of equipment maintenance programs, and proper data and specimen management.
- Provide support, investigative consultation, and monitor effective resolution for site laboratory testing, protocol issues and applicable quality system problems.
- Review and analyze site labs' workload, performance and adherence to approved Quality Assurance Program.
- Communicate as needed with Division of AIDS or DAIDs contractors.
- Provide site lab support, training and protocol lab practice reviews through regular site visits, conference calls or other appropriate media; adapt communication styles based on targeted audience and topic.
- Provide oversight for Peripheral Blood Mononuclear Cell (PBMC)/serum/plasma processing and cryopreservation training and certification program.
- Provide PBMC External Quality Control program support including analysis, interpretation and reporting to sites. Review adequacy of site response on EQC reports.
- Manage site supply program including resourcing new supplies and vendors, monitoring site delivery system and oversight of invoices.
- Develop and implement site training programs and tools for new specimen processing techniques that include quality assurance practices.
- Provide LDMS (centralized laboratory data management system) support to sites; provide program input to the developer, Frontier Science.
- Provide input and support to HVTN and client protocol teams regarding local lab testing/methodologies, processing, storage and shipping of specimens.
- Provide input and support to for HIV/AIDS Network Coordination (HANC) lab programs, including the Lab Focus Group.
- Coordinate, participate and support the efforts of the HVTN Laboratory Program and perform additional activities as necessary.

- B.S/B.A. required - preferably in a scientific field with Minimum 5 years of experience in clinical safety laboratory.
- Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance
- Experience in clinical safety laboratory management, PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials preferred
- Understanding of HIV diagnostics testing preferred
- Computer skills - including Microsoft Word, Excel, PowerPoint and other laboratory-specific programs
- Ability to work in a team
- Good numeracy, literacy and organizational skills
- Good interpersonal and time management skills
- Willingness to be flexible in working hours, be willing to travel as needed (up to 15%), and work some evenings and weekends. 

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