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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.

The focus of responsibilities for the Quality Assurance Associate I-II is to provide oversight, coordinate and facilitate clinical site specimen processing and clinical testing lab projects and programs for the HVTN Laboratory Operations Unit. The QA/QC Associate I vs. II designation will be based on candidate's qualifications and related experience.

This is a hybrid role. The hours are Monday-Friday 8-5pm PST.

Provide QA oversight to processing labs associated with HVTN clinical trials, including:

Provide oversight for domestic and international network site labs for HVTN study preparation.
• Provide site training, develop and communicate study-related lab practices and operations.
• Determine network lab equipment needs.
• Monitor Good Clinical Laboratory Practice compliance, workload, and other key quality indicators that may impact deliverables.
• Provide input and support to other divisions within the HVTN and client protocol teams for specimen processing, storage, and shipping, as well as clinical lab testing/methodologies.
• Facilitate implementation of specimen management programs for study-related specimens including data entry and electronic systems support.
• Provide oversight for specimen processing and cryopreservation training and certification program.
• Provide peripheral blood mononuclear cell (PBMC) External Quality Control program support including analysis, interpretation and reporting to sites.
• Review adequacy of site response on External Quality Assurance reports related to peripheral blood mononuclear cell (PBMC) processing.
• Collaborate with other divisions within the HVTN to support network clinical trials and represent the HVTN Laboratory Operations Unit in interactions with stakeholders.
• Provide network lab support and training through regular laboratory visits (virtual or physical), conference calls, or other appropriate media. Must be able to adapt communication styles based on targeted audience and topic.
• Assist site labs with implementation of individualized Quality Assurance plans and related QA systems, such as local document control and equipment maintenance programs.
• Coordinate, participate in, and support the efforts of the HVTN Laboratory Operations Unit and perform additional activities as necessary.

REQUIRED EDUCATION AND EXPERIENCE:

• B.A./B.S. in a medical science field.
• Minimum requirement - QA/QC level I is 0-2 years of cellular or biological manufacturing exp. or an equal combination of education and working experience
• Minimum requirement - QA/QC level II is 2-5 years of cellular or biological manufacturing exp. or an equal combination of education and working experience
• Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance.
• Demonstrated experience in clinical safety laboratory management.
• Ability to work with minimal supervision.

PREFERRED QUALIFICATIONS:

• At least 5 years of experience as a medical laboratory scientist or equivalent strongly preferred.
• At least 1 year of experience in quality assurance.
• Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials.
• Understanding of HIV diagnostic testing
• Computer skills, including Microsoft Word, Excel, PowerPoint, and laboratory-specific programs.
• Good numeracy, literacy, and organizational skills.
• Good interpersonal communication and time management skills.
• Willingness to be flexible in working hours, be willing to travel as needed, and work some evenings and weekends.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

QA/QC Level I: The annual base salary range for this position is from $67,716 to $99,236, and pay offered will be based on experience and qualifications.

QA/QC Level II: The annual base salary range for this position is from $76,606 to $114,878, and pay offered will be based on experience and qualifications.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).