• Senior Coordinator - Investigational Products Quality Assurance

    Job Locations USA-NY-New York
    Posted Date 1 month ago(9/16/2019 4:06 PM)
    Requisition ID
    2019-36501
    Category
    Research - Clinical
  • 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 28th 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 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.

    Job Description

    Do you have an interest in the manufacturing of investigational products for clinical trials?

     

    We are seeking an experienced Quality Assurance professional to join our dynamic Investigational Products Quality Assurance team. As a Senior Coordinator you will support MSK labs and facilities to ensure investigational products are developed and manufactured in compliance with institutional policies and outside regulatory requirements. In this role, you will ensure that investigational product facilities, pharmacies and laboratories adhere to the regulations set forth by the FDA and other regulatory agencies regarding Good Laboratory Practices (GLP), Good Manufacturing Practice (GMP), and Good Tissue Practices (GTP).

     

    You Will:

    • Conduct QA reviews or inspections of non-clinical product development studies, including GLP-compliant studies.
    • Support the development and qualification of new MSK facilities for non-clinical and GMP work.
    • Review all new manufacturing, pharmacy and laboratory operations QA documentation as per the requirements in MSKCC policies and procedures.
    • Prepares review comments and communicates findings to appropriate MSK staff and IPQA Manager.
    • Identify significant events, critical issues or issues related to product safety and efficacy and on the same day communicate to the IPQA Manager.
    • Participate in the implementation of new or changed quality practices for MSK manufacturing and testing facilities, contracted third party facilities, and research pharmacies to ensure compliance with regulations and institutional policies.
    • Participate in or lead manufacturing failure, out-of- specifications, product complaint and other investigations. Communicate issues and concerns to CRQA management in a timely manner.
    • Support any additional quality assurance initiatives and responsibilities as defined by management.
    • Conduct audits of manufacturing facilities, research pharmacies and the Antitumor Assessment GLP facility according to MSKCC policy, CFR’s and GMP guidelines.
    • Document audit findings and observations

    You Are:

    • Experienced in QA and continuous improvement principles and their application
    • Able to work independently with little or no supervision.
    • Able to work effectively in an environment notable for complex, sometimes contradictory information.
    • Flexible in your approach and demeanor in order to align with the shifting demands of evolving circumstances.
    • An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding.

    You Have:

    • A Bachelor's degree or the equivalence of work experience
    • QA Experience in a GMP setting
    • QA/QC Experience and experience working with the FDA or other regulatory agencies
    • Experience with audit and product development
    • Supervisory experience preferred
    • Project experience as a lead or individual contributor is useful

    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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