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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is seeking a Clinical Quality Assurance Specialist to join the Quality Assurance Team to provide quality support of clinical trial research.
Works with the Quality Assurance Team to develop, implement, maintain and monitor the comprehensive quality management system (QMS), including
SOP Document Control
Employee SOP/Compliance Training
CAPA Implementation and Reporting
Internal Quality Audits
External Audits and Inspections
System Validation Review and Archive
Quality Department Process Improvement Initiatives
Bachelor's degree* with 2+ years of experience implementing typical quality assurance activities, including:
Facilitating internal audits of processes, study documentation, and records, as well as, maintenance of related records.
Preparing and/or participation in client or regulatory audits and maintenance of related records.
Identification and reporting of incidents/deviations, maintenance of related reports and documents, implementation of corrective and/or preventive actions.
Assignment and tracking of staff training and maintenance of training records.
Review, development and revision of procedures (SOPs), as well as, maintenance of controlled documents and related records.
Qualification of suppliers/vendors and maintenance of related documentation.
Review of system validation documentation and maintenance of related records.
*Progressive experience in implementing quality systems may substitute educational requirement.
Seeking Key Characteristics
Effective written and verbal communication skills
Proficiency in MS Office Applications
Ability to multi-task and meet target dates
Strong organizational skills
Ability to maintain accurate and detailed records
Preferred Experience, but not required
Familiarity with Good Clinical Practices (GCP) in a clinical trial atmosphere
Experience using MasterControl or similar eQMS system
We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 email@example.com or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.