The Cellular Processing Facility managed by the FredHutchinsonCancerResearchCenter is responsible for manufacturing activities related to the preparation of cell products that are utilized in early phase clinical research protocols. All products manufactured by the Cellular Processing Facility must meet required Food and Drug Administration (FDA) regulations for potential use in human clinical studies. The SCCA Cellular Therapeutics Quality Assurance department currently provides quality oversight for the FH for the Cell Processing Facility.
The CTP Quality Assurance Associate 2 is a support role for the Quality Specialist overseeing the CPF manufacturing area.
The Quality Associate 2 is responsible for the review of manufacturing records for the products that are manufactured in this area under specific protocols, IDEs or INDs as required. Additionally, this position may be responsible for the release of these products per approved quality systems and protocol specifications. The Quality Assurance Associate is responsible for review and approval of deviations, CAPAs, raw material release, quality control data, SOP revisions, batch record revisions, etc.
The Quality Assurance Associate is responsible for sending Supplier Questionnaires. The Quality Assurance Associate is responsible for assisting in the review and creation of controlled documents in support of quality system improvement. CTP Quality Assurance Associate is responsible for assisting and may at times represent the Quality department on Operational led project teams; providing regulatory and accreditation standard insight in support of the project goals and deliverables.
The CTP Quality Assurance Associate is responsible for assisting in organizing, planning, managing and implementing Quality Improvement projects as assigned and/or prioritized by the CTP Quality Specialist. The Quality Associate will assist and or perform audits of existing systems such as environmental monitoring and equipment management Excellent communication skills are required in working with project team leads, members, staff and managers; collaboration with FHCRC partners and coordination with Principal Investigators.
- B.S. degree with a major in biological science, medical technology or related discipline. 2-5 years of cellular or biological manufacturing experience including quality assurance responsibilities. Working knowledge of cGMP/cGTP regulations is required.
- Experience with computer databases including statistical software preferred.
- Previous experience with quality systems, quality control and EDMS system required
- Previous project management or project oversight experience desired
We are a VEVRAA Federal Contractor.
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