Quality Assurance (QA) Specialist

USA-NY-New York
1 month ago(12/6/2017 2:58 PM)
Requisition ID
2017-16012
Category
Research - Other

Company Overview

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.

Job Description

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

 

Requirements

Master’s Degree with 3 – 5 years quality experience in the field of cell therapies #LI-SB1

Closing

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.

 

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