Quality Assurance Associate I - Seattle, United States - Fred Hutchinson Cancer Center (Fred Hutch)

Description

Quality Assurance Associate I - HVTN Lab Operations

Job ID

27510

Type

Regular Full-Time

Location

US-WA-Seattle

Category

Quality

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 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 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 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.

Under the direction of the HVTN Associate Director for Laboratory Operations and the HVTN Quality Assurance Associate II, the Quality Assurance (QA) Associate I will participate in the development, implementation and maintenance of quality assurance systems and activities related to all aspects of HVTN Immunological Endpoint Assay and Specimen Processing Laboratories. This will include, but is not limited to, the duties described below.

Responsibilities

Conduct laboratory audits and informal inspections to ascertain all activities conform to Good Clinical Laboratory Practices (GCLP) standards
• Coordinate with laboratory manager and related stakeholders to describe or determine the scope of objectives, and scheduling of internal and external study sponsor audits
• Formally document audit findings and report to HVTN Laboratory QA Associate II and Associate Director
• Work with laboratory managers and staff to facilitate resolution of compliance issues and incident management. Inform management of issues that require their attention, provide recommendations, track corrective actions for effectiveness and communicate status of action resolution
• Maintain electronic QA systems (document control)
• Audit final study reports to ascertain that the reports reflect 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 Standard Operating Procedures (SOPs)
• Maintain document control and historical archive of SOPs
• Obtain documented commitments for corrective actions and associated follow-up to verify implementation of identified measures
• Facilitate internal and external proficiency/quality assurance testing and evaluation
• Host external regulatory inspections and audits

Additionally, the QA Associate I will work collaboratively with the central HVTN Quality Assurance program. This includes interacting with the QA managers and network laboratories to help ensure compliance with HVTN procedures and with the NIH's Division of AIDS (DAIDS) GCLP guidelines. Central QA activities will include but are not limited to:

• Collaborate with the development, implementation, control, and distribution of SOPs
• Support quality assessment and improvement activities for the Network; provide consultative services as appropriate
• Other duties as assigned

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor of Science degree in a scientific discipline, or related field
• Minimum requirement of 1 year of related experience

PREFERRED QUALIFICATIONS:

• At least 1-2 years of experience as a medical laboratory scientist or equivalent strongly preferred
• At least 1 year of experience in quality assurance
• Familiarity with regulatory requirements for laboratory-based immunogenicity studies
• Experience working in a GCLP, CLP and/or GMO regulated setting
• Familiarity with Cellular immune monitoring techniques preferred
• Experience in immune monitoring of vaccine clinical trials or vaccine development preferred
• Membership/certification in Society for Quality Assurance (SQA) strongly preferred
• Understanding of HIV diagnostics testing
• Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials
• Work experience with LIMs systems, LDMS, Labware
• Experience with document control systems (e.g., Veeva Vault)
• 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
• Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance
• Demonstrated experience in clinical safety laboratory management
• Ability to work with minimal supervision
• Experience with performing internal audits and preparation for external audits

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 hourly pay range for this position is from $32.57 to $47.71 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 days per year), paid sick leave 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 or by calling