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At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
For the 27th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2016, as well as Glassdoor’s annual Employees’ Choice Awards 2017. We’re treating cancer, one patient at a time. Join us and make a difference every day.
The Adoptive Immune Cell Therapy Facility (AICTF) 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. In order to prepare all documentation required for successful licensing of an Epstein Barr Virus-Specific Cytotoxic T Lymphocytes (EBV-CTL) product by the FDA, additional Quality and clerical staff is required to be hired for the AICT Facility.
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 AICTF QA Manager to provide staff training for critical production steps of the AICTF 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 AICTF.
- Work closely with the QA Manager in preparing the AICTF 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 AICTF for clinical use.
- Ascertains timely collection and storage of documentation supporting proper validation of the reagents, supplies and equipment used by AICTF
- Reviews batch records to ascertain timely data entries and accuracy of the procedures performed in accordance with the current SOPs approved for the AICTF activities
- Reviews QA/QC documentation and prepares QC certificates for AICTF product certification
- Conducts investigation of the product failure , procedure deviations and violations
- Releases reagents and supplies for the AICTF production based on documentation provided by the manufacturer or based on the validation data generated by the AICTF 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 AICTF staff
- Supports all functional Quality Assurance activities related to the development, implementation and maintenance of AICTF 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 AICTF
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.
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