The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at Fred Hutchinson Cancer Research Center in Seattle, Washington is seeking a Clinical Quality Assurance Specialist III with MasterControl experience.
The Clinical Quality Assurance Specialist III is a member of the quality team and provides quality support to ensure compliance with industry guidelines and regulations. The Clinical Quality Assurance Specialist III will work with the quality team to develop, implement, maintain and monitor all aspects of the comprehensive quality program in support of clinical trial research.
This position reports to the Quality Assurance Manager.
- Leads quality activities.
- Provides guidance to junior quality team members and SCHARP staff.
- Implements and manages the document control system. Ensures regular review and development of SOPs.
- Assigns and tracks training for all staff. Develops training materials and facilitates training to staff.
- Implements the internal audit program. Schedules, facilitates, documents and tracks internal audits.
- Manages and tracks the incident report and CAPA program. Works with CAPA owners and managers to develop appropriate documentation, investigate issues, recommend appropriate corrective and preventative actions, and monitor effectiveness.
- Hosts client audits and/or regulatory inspections. Schedules, creates reports and responds to observations and questionnaires, as assigned.
- Reviews and approves computer system validation documentation.
- Implements the vendor qualification program. Schedules and facilitates audits of suppliers and vendors.
- Bachelor's degree with direct experience implementing and leading a comprehensive quality system in a regulated environment. 6 years of progressive experience in implementing quality systems may substitute educational requirement.
- 4 years of experience implementing quality assurance across a company.
- Experience implementing MasterControl QMS is strongly desired.
- Working knowledge and understanding of Good Clinical Practices (GCP) relating to clinical trials.
- 1 year in a senior or lead quality role.
ABOUT FRED HUTCH and SCHARP
Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for our pioneering work in bone-marrow transplantation, the five scientific divisions at Fred Hutch collaborate to form a unique environment for conducting basic and applied science. Fred Hutch, in collaboration with its clinical and research partners, the University of Washington and Seattle Children's, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest.
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) provides statistical collaboration to infectious disease researchers around the world and conducts a complementary program of statistical methodology, and mathematical modeling research. SCHARP also collects, manages, and analyzes data from clinical trials and epidemiological studies dedicated to the elimination of infectious disease as a threat to human health. Current projects include studies to evaluate and implement prevention strategies for HIV, tuberculosis, polio, malaria and other globally important pathogens. Join us and make a difference!
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