Memorial Sloan-Kettering Cancer Center Investigational Product Quality Assurance Specialist in New York, New York
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.
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.
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.
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.
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
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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CategoryResearch - Clinical