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).
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, CFRs and GMP guidelines.
Document audit findings and observations
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.
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
Internal Number: 2019-36501
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.