QA Associate II - CTP

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. 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.

The Cellular Therapeutics group is responsible for all therapeutic cellular collection and processing occurring at the Fred Hutchinson Cancer Center. All products manufactured by the Apheresis Unit or Cellular Therapy Laboratory must meet or exceed required Food and Drug Administration (FDA) regulations for potential use in human clinical studies, as well as compliance with the Foundation for the Accreditation of Cell Therapy (FACT) standards, and other applicable governing agency regulations.

The Quality Assurance Associate II is responsible for assisting in the development and monitoring of quality systems that support cellular collection, processing and infusion for the Cellular Therapeutics Apheresis Unit and Cellular Therapy Laboratory. A person in this position exercises judgment within defined procedures and practices to determine appropriate action; tasks are typically carried out with general instruction on routine work, detailed instruction on new assignments or in collaboration with colleagues.

This is a full-time, salaried position and located onsite Monday-Friday 9am-5:30pm.

• Participate in development and implementation of quality systems to assure compliance with relevant standards and regulations; specifically, but not limited to cGTP, cGMP and FACT.
• Identify deviations or potential sources of deviations during product processing records review and product release. Work with Operational management to ensure timely submission of deviations.
• Review, evaluate and investigation deviations; coordinate corrective actions with Operational staff. Work with Operational management to properly close variances.
• Perform investigations on issues related to product quality. Perform root cause analysis, identify issues and potential corrective and preventative actions (CAPA).
• Review product processing records to ensure compliance with standard operating procedures (SOP) and release criteria. Ensure processing adheres to Sponsor specific requirements for clinical trials/commercial products as outlined on protocol/product specific batch records. This includes performing read offs with Operational staff and resoling issues during the release process.
• Provide QA support in developing and executing new or nonstandard procedures and processes as needed.
• Assist with training staff on Quality systems.
• Work with the Quality Assurance Specialist(s) to identify and develop quality indicators based on improvement efforts and quality led projects.
• Author, review and qualify controlled documents such as SOPs to achieve compliance with regulatory and accreditation requirements.
• Perform in-process improvement projects as a Quality Subject Matter Expert (SME). Ability to recommend changes to controlled documents as necessary.
• Learn and be able to perform all Document Control responsibilities and act…