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 27th 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 2016, as well as Glassdoor’s annual Employees’ Choice Awards 2017. We’re treating cancer, one patient at a time. Join us and make a difference every day.
Reporting directly to the Investigational Product Quality Assurance Manager, the Investigational Product Quality Assurance (IPQA) Specialist participates in ensuring that MSKCC investigational products for our clinical trials are developed and manufactured in compliance with institutional policies and outside regulatory requirements.
Conduct institutionally-required QA oversight functions for all investigational products at MSKCC.
Provide QA services as identified and assigned by the IPQA Manager.
Assist to ensure that investigational product facilities, pharmacies and laboratories adhere to the regulations set forth by the FDA and other regulatory agencies regarding Good Manufacturing Practice (GMP), Good Tissue Practices (GTP), and Good Laboratory Practices (GLP).
Bachelor’s degree with at least 2 years of relevant experience.
Master’s degree in Science, related to medicine or medical product development preferred.
1 or more years experience with each of the following preferred: QA/QC, FDA/other Regulatory agencies guidance and regulations, Industry, management/leadership, Product Development, and Auditing.
Communication Skills: The ability to develop, facilitate, and orchestrate effective communication with all members of MSK; responsible for the writing, preparing and educating staff on clinical research procedures and processes. Individual must be able to communicate effectively with all levels of staff including clinical staff (investigators, nurses etc), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors. Excellent oral and written communication skills are required.
Federal Regulations: Must have knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) for investigational product development and manufacturing. Responsible for participating in the writing/preparing and educating on the MQS Standard Operating Procedures, system and processes.
The ability to effectively communicate with all members of the Manufacturing Quality System; responsible for communicating activities and responsibilities of MQS and to the appropriate laboratory and clinical investigators, external sponsors or organizations that we share our work efforts and institutional leadership, as appropriate.
Information Management Skills: The ability to communicate, explain, interpret, share and present information to employees, management and clinical staff and patients at MSK as well as appropriate external contacts.
Analytical Skills: A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Excellent problem-solving ability. Ability to analyze situations, draws conclusions, make recommendations and convey information in a timely and proficient manner. Strategic thinker. The ability to perform basic math calculations and as well as some knowledge of statistics.
Time Management Skills: The ability to set priorities among several tasks simultaneously and meet established deadlines. Ability to manage multiple large scale development projects simultaneously. Ability to guide staff to ensure programmatic activities adhere to established time frames and deadlines.
Administrative Skills: The ability to plan, organize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
Computer Skills: Proficiency in use of computers and software such as database management, spreadsheet, word processing and graphics applications. Knowledge of mainframe systems utilized at MSKCC is essential.
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.
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, a...nd 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.