Specialist, Investigational Product Quality Assurance

Memorial Sloan-Kettering Cancer Center | New York, NY, United States

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Posted Date 4/15/2021

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. We’re treating cancer, one patient at a time. Join us and make a difference every day.

Job Details

We are seeking an experienced Quality Assurance professional to join our dynamic Investigational Products Quality Assurance team. You will support MSK labs and facilities to ensure investigational products are developed and manufactured in compliance with institutional policies and regulatory requirements. You will ensure that our facilities, pharmacies, and laboratories adhere to regulations 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 manufacturing, pharmacy, and laboratory operation documentation as per the requirements in MSK policies and procedures.

- Prepares review comments and communicates findings to appropriate MSK staff and 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.

You Are:

- Experienced in QA and continuous improvement principles and their application

- Able to work effectively in an environment notable for complex, sometimes contradictory information.

- 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 with 2-3 years of related work experience preferred

- QA/QC Experience and experience working with the FDA or other regulatory agencies preferred

- Experience with audit and product development

Research and Development

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