Quality Assurance (QA) Program Specialist Apply
Overview
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the worlds leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the worlds deadliest diseases and make life beyond cancer a reality.At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.
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 HVTNs 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 Program Specialist is to provide oversight, coordinate and facilitate clinical site specimen processing and clinical testing lab projects and programs for the HVTN Laboratory Center Operations Division. This role will include providing strategic leadership to the Americas HVTN LC Operations team, coordinating and prioritizing team activities, tracking individual and team task progress, and ensuring adequate coverage and support to all Americas network laboratories.
This is a hybrid role
Responsibilities
PRIMARY/ESSENTIAL DUTIES:
Will provide QA oversight to processing labs associated with HVTN clinical trials by:
- Overseeing, monitoring, and providing support to the Americas Laboratory Center Operations Team.
- Routinely reporting team updates to Lab Center leadership.
- Assessing and adjusting team priorities as required.
- Managing resources and allocation of tasks.
- Coordinating day to day activities and tracking tasks of individuals as well as the team.
- Ensuring effective completion of projects.
- Ensuring adequate coverage and support to all specimen processing labs.
- Planning, monitoring, and evaluating outcomes of team deliverables.
- Facilitating/coordinating required and ad hoc training for local team.
- Implementing and monitoring LC teams adherence to LC standard operating procedures and work practice guidelines.
- Working collaboratively with team to resolve operational problems and coordinating efforts with leadership when escalation is required.
- Participating in external audits of LC.
- Contributing to local team and larger LC Operations team by accomplishing team objectives as needed.
- Coordinating efforts related to training new local team members.
- Providing monitoring of local laboratory workflows, practices, and results for HVTN clinical trial specimens through regular site visits and contact including conference calls and email.
- Managing the HVTN PBMC quality program for Americas including oversight of PBMC quality control assessments and reporting and provision of corrective action support and retraining as needed.
- As needed and working in close collaboration with other HVTN staff, participating in teams that support the implementation of HVTN clinical trials in the Americas; this may include contributing to the design of clinical monitoring plans.
- Other duties and assignments as requested for the overall performance of the department and company.
- Communicating information, as directed, from HVTN Laboratory Center Operations leadership to the Americas team, and communicating team and project status to HVTN LC Operations leadership.
- Providing evaluation, oversight, and review of local rapid, safety and processing laboratories used for HVTN clinical trials in the Americas.
- Providing training for laboratory practices related to HVTN clinical trials.
- Monitoring external quality assessment programs for safety testing and diagnostics.
- Providing evaluations, corrective action support and retraining as needed for potential problem areas.
- Assisting with development and implementation of special projects such as regional laboratory training programs, pilot studies or new specimen processing techniques as needed.
- Providing PBMC External Quality Control (EQC) program support including analysis, interpretation and reporting to sites. Review adequacy of site response on EQC reports.
- Communicating program needs to HVTN Laboratory Center leadership; ensure sufficient balance of routine workload and quality assessment programs.
- Assisting local laboratories with implementation of, and adherence to, Good Clinical Laboratory Practices (GCLP).
- Assisting Clinical Research Sites (CRS) with implementation and management of specimen collection, processing, and logistics for HVTN Core team.
- Laboratory development and training of new Specimen Processing laboratories.
- Performing additional laboratory activities as necessary to support HVTN clinical trials.
- Other duties as assigned.
Qualifications
Required Qualifications:
- B.A./B.S. in a medical science field.
- Minimum 7 years of experience in clinical safety laboratory or equivalent relevant experience.
- Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance or equivalent relevant experience.
- Minimum 3 years of experience as a QA Associate or in an equivalent role.
- Previous clinical safety laboratory management and project oversight experience.
- Ability to work with minimal supervision.
Preferred Qualifications:
- At least 7 years of experience as a medical laboratory scientist or equivalent relevant experience strongly preferred.
- At least 3 years of experience in quality assurance.
- Understanding of HIV diagnostics testing.
- Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials.
- 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.
The annual base salary range for this position is from $88,670 to $132,974, 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).
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.
