QA Associate II - CTP

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 Cellular Therapeutics group is responsible for all therapeutic cellular collection and processing occurring at the Fred Hutchinson Cancer Center (FHCC). 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 judgement 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.

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 as backup to the role of Document Control Specialist as needed.
• Familiarity with CTP Quality Systems/functions such as, but not limited to, CAPA/EC, supplier/vendor qualification, cellular therapy product manufacture qualification, change control, engraftment data management including delayed/failed engraftment investigation, serious adverse reaction investigation, and others.
• Other duties as assigned.

Required:

• A Bachelor of Science degree in a scientific discipline including pharmaceutical, biologics, or related field and/or a minimum of 3 years of cellular or biological manufacturing experience, quality responsibilities or an equal combination of education and working experience
• 3 years of cellular or biological manufacturing experience, quality responsibilities or an equal combination of education and working experience
• Working knowledge of cGMP/cGTP regulations with prior experience working in a regulatory environment
• Able to communicate ideas effectively both verbally and in writing and to facilitate change.
• Able to interact constructively with peers, management and outside contacts.
• Experience with computer databases and competent with MS Office programs.
• Excellent interpersonal skills.
• Proven ability to multi-task and strong attention to details and accuracy

Preferred:

• Working knowledge of FACT standards
• Experience with batch record review/approval, performing investigations, performing audits
• Previous experience with Laboratory Information Management Systems (LIMS) and Part 11 compliance
• Previous project management or project oversight experience
• Experience generating documents intended for use in a GxP environment or regulatory filing

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 $71,552 to $107,328 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).