The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe. One of the world’s most respected comprehensive centers devoted exclusively to cancer, we have been recognized as one of the top two cancer hospitals in the country by U.S. News & World Report for more than 30 years.

Pay Range: $73,900.00-$114,400.00

Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.

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Job Description: QA Coordinator, Cell Therapy, and Cell Engineering Facility

Summary:
We are seeking a meticulous and proactive Quality Assurance Coordinator to join our team. This role entails managing vendor relationships, coordinating schedules, developing quality agreements, conducting audits, following up on testing results, assisting with CMC preparation, and ensuring that our operations comply with regulatory standards.

Role Overview:
- Vendor Relationship Management: Handle all external vendor interactions, including SOWs, contracts, SOPs, quotes, and budgets. Update relevant documents as necessary.
- Vendor Qualification: Conduct and document vendor qualifications, manage contract submissions, oversee the controlled stability of vectors, and assist in vendor audit activities.
- Quality Agreement Management: Manage and facilitate the review process for quality agreements.
- Sample Testing Coordination: Review sample testing and shipment requirements, prepare submission forms, schedule, and coordinate shipments for external testing, ensuring compliance.
- Testing Results Follow-Up: Ensure timely and efficient follow-up on testing results.
- Smartsheet Maintenance: Maintain Smartsheet for external testing, ensuring it includes all required external submissions.
- Raw Material Qualification: Coordinate raw material qualifications and ensure all material COAs/COCs are sourced at the time of ordering and receipt.
- Procurement Info Management: Update and maintain procurement and qualification information presentation files for key reagents, such as plasmid, FBS, and human serum.
- CMC Preparation Support: Assist in CMC preparation, including project onboarding, discussions, email chains, and documentation.
- CMC Response Management: Maintain and organize responses related to CMC, including testing, holds, and other topics.
- Regulatory Compliance: Prepare and respond to FDA inquiries, ensuring compliance and timely communication.
- Product Test Record Review: Review product test records for completeness and accuracy.
- Quality Concerns Management: Raise quality concerns when appropriate and assist in planning, implementing, and following up on corrective actions.
- Change Requests and SOP Updates: Assist in change requests, SOP, and MPCR updates, ensuring they are housed in the Quality Plan (QP).
- Purchase Order Guidelines: Create and upload guidelines for purchase order management and invoice approvals.

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