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The Center for Immune Cell Therapies (CICT) at MSK is a part of the Center for Cell Engineering which was established to foster research on cellular therapies. We are currently seeking a Quality Assurance (QA) Assistant to generate new Standard Operating Procedures (SOPs), revise old SOPs, monitor and maintain SOPs under supervision of the QA Specialist and QA Facility Manager.
Work closely with QA Specialist to review batch records, paper forms, and lab books of every product and grouping of data for comparative analysis to ensure that every product can meet the GMP requirements for processing, manufacturing and documenting of the production steps.
Assist with final preparation of the PDF batch records requiring data allocation, data collection, paper form scanning, generation of PDF forms from the data base, data and forms grouping
Assist with collection, analysis and summary of the data of the freezing program performed by other team members to have it immediately available for any audit
Review and revise old and current SOPs under supervision of the QA Specialist, report changes to the QA Manager and to the CICT Director
Assist other members of the QA/QC group with sorting of the products based on their batch records based on the modifications of the SOPs into the eras of productions with the summary of the test results
In collaboration with the QA Specialist conducts regular reviews of the CICT SOPs for the concordance with the most current practice
Maintain, monitor and track changes of the CICT SOPs
Assist with collection and summary of all deviations identified in the process of products receipt, preparation, processing, production, storage, infusions, use, testing and results of investigations and retraining
Initiates revision, implementation and maintenance of standard operating procedures (SOPs) according to good manufacturing practices (GMP) and FDA approved guidelines for the CICT under supervision of the QA Specialist.
Confirm the accuracy and completeness of the manufacturing steps recorded in the batch records as per current SOPs under supervision of QA Specialist.
Bachelor's with at least 2 years quality experience in the field of cell therapies
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
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As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, a...nd superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.