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Investigational Product Quality Assurance Specialist

LocationNew York, NY

Ref2019-29380

DeptResearch - 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 Details

Are you passionate about continuous improvement? Do you have an interest in the manufacture of investigational products for clinical trials?

We are looking for a detail-oriented Investigational Product Quality Assurance Specialist to join our Clinical Research Quality Assurance team. On this team, we support MSK labs and facilities to ensure investigational products are developed and manufactured in compliance with institutional policies and outside regulatory requirements.

You Will:

  • Conduct institutionally-required QA oversight functions for all investigational products and provide QA services as needed.
  • Assist in ensuring investigational product facilities, pharmacies and laboratories adhere to the regulations set forth by the FDA and other regulatory agencies Good Manufacturing Practice (GMP), Good Tissue Practices (GTP), and Good Laboratory Practices (GLP).
  • Conduct quality assurance activities for batch production and accountability records for lots produced.
  • Support quality assurance activities associated with the MSK quality system, investigational product manufacturing and departmental projects.
  • Support QA reviews and inspections of non-clinical product development studies, including GLP-compliant studies.

You Are:

  • A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
  • Focused on continuous improvement, knowing the most effective and efficient processes to optimize work flow.
  • An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding.
  • Able to operate effectively, even when things are not clear or the way forward is not obvious.

You Have:

  • A Bachelor's degree or HS Diploma/GED with 2-4 years of relevant experience
  • At least 1 year of QA/QC experience and experience with FDA/other regulatory agencies guidance and regulations
  • Experience with audit and product development are helpful

Application Hiring Process

Step 1
Complete an Online Application
Step 2
Complete an Online Assessment
Step 3
Participate in an Initial Phone Interview
Step 4
Participate in In-Person or Video interviews
Step 5
Provide References
Step 6
Extension of Job Offer
Step 7
Onboarding
Step 8
New Employee Orientation
Step 1
Complete an Online Application
Step 2
Complete an Online Assessment
Step 3
Participate in an Initial Phone Interview
Step 4
Participate in In-Person or Video interviews
Step 5
Provide References
Step 6
Extension of Job Offer
Step 7
Onboarding
Step 8
New Employee Orientation

New York, NY

At MSK, we are committed to providing exceptional patient care that is as convenient as possible. Each of our facilities serves a purpose and is strategically built to support a larger community, including our employees.

Learn more

Nearest location

Memorial Hospital
New York, NY
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