Fred Hutchinson Cancer Research Center Quality Assurance Associate II in Seattle, Washington
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 world’s 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 world’s 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 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.
Under the direction of the HVTN Quality Assurance Program leadership, the QA Associate will be responsible for participating in the development, implementation, and maintenance of quality assurance systems and activities related to all aspects of the Seattle HVTN Immunological Endpoint Assay and Specimen Processing Laboratories, and related research laboratories.
This will include but is not limited to:
Conduct laboratory audits and informal inspections to ascertain that all activities conform to GCLP and internal standards.
Coordinate the scope, objective, and scheduling of audits with Laboratory Management.
Formally document and report quality findings to HVTN Laboratory and QA leadership.
Facilitate continuous improvement initiatives and compliance issue resolutions with laboratory personnel.
Provide recommendations, monitor and communicate status of action plans, and bring to management issues that require attention.
Maintain QA systems, including online document libraries, lists, tasks, and workflows.
Provide GCLP and quality system training to laboratory personnel.
Assist departmental managers with new employee orientation and training file management.
Monitor training records and proficiency evaluation program.
Audit study reports and data to ascertain that the study was conducted with integrity and the reported results reflect the performance of the study.
Monitor pertinent laboratory documents, procedures, and processes for their adherence to GCLP principles.
Assess clarity and GCLP compliance of new and revised SOPs.
Facilitate document change control and maintain historical archive of study-related documents.
Monitor / measure key quality indicators and report trends to laboratory leadership as appropriate.
Obtain commitments for corrective actions and follow up to verify the implementation of any such measures.
Host external regulatory inspections and audits.
Assist with the acquisition of laboratory supplies for network laboratories.
BS degree in an appropriate scientific field.
At least 3 or more years of experience working in a GCLP and/or GMP-regulated setting (or similar), quality responsibilities or an equal combination of education and work experience.
Familiarity with regulatory requirements for laboratory-based immunogenicity studies is preferred.
Familiarity with cellular immune monitoring techniques is preferred.
Experience in immune monitoring of vaccine clinical trials or vaccine development preferred.
Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).
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 $70,817 to $106,225 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).
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 our Employee Services Center at firstname.lastname@example.org or by calling 206-667-4700.
External Company URL: http://www.fredhutch.org/careers
Street: 1100 Fairview Ave N