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The Center for Immune Cell Therapies ( CICT) at Memorial Sloan Kettering Cancer Center has entered a Phase II Study of the therapeutic effects of Epstein-Barr Virus (EBV) immune t-lymphocytes in the treatment of EBV lymphoproliferative disorders and EBV-associated malignancies.
We are currently seeking a Quality Assurance (QA) Specialist to oversee all aspects of quality control system and in-house quality control procedures. As a QA Specialist, you will work under the general direction of the CICT QA Manager to provide staff training for critical production steps of the CICT and develop new procedures improving clinical production and proper documentation of manufacturing activities. Additional responsibilities include but are not limited to:
Work closely with the QA Manager to development, revise, implement and maintain standard operating procedures (SOP's) according to good manufacturing practices (GMP) and FDA approved guidelines for the CICT.
Work closely with the QA Manager in preparing the CICT for internal or external audits and inspections by any authorized agencies including FDA
Oversees and assists with validation testing
Oversees collection of the QC test documentation from outside testing laboratories, collaborators used to certify and qualify the products received, stored and generated by CICT for clinical use.
Ascertains timely collection and storage of documentation supporting proper validation of the reagents, supplies and equipment used by CICT
Reviews batch records to ascertain timely data entries and accuracy of the procedures performed in accordance with the current SOPs approved for the CICT activities
Reviews QA/QC documentation and prepares QC certificates for CICT product certification
Conducts investigation of the product failure , procedure deviations and violations
Releases reagents and supplies for the CICT production based on documentation provided by the manufacturer or based on the validation data generated by the CICT QA group
Ensures radioactive monitoring of the areas involved in the use of radioactive materials
Oversees proper labeling and distribution of supplies and reagents
Under general direction develops and validates new bioassays and equipment.
As requested performs assays required for testing and characterization of cell products generated by CICT staff
Supports all functional Quality Assurance activities related to the development, implementation and maintenance of CICT Quality systems such as Document Control, Change Control, Deviations, and CAPAs etc.
Oversees shipment of test samples to external testing sources and acquisition of test reports.
Performs Vendor qualification and vendor selection
Requests additional QC testing required to certify the products received, processed, generated and stored in CICT
Master's Degree with 3 – 5 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.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
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.