Details
Posted: 19-Sep-23
Location: New York, New York
Salary: Open
Categories:
Allied Health
Pay Range
$106,500.00-$170,400.00
Company Overview
The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe. One of the world's most respected comprehensive centers devoted exclusively to cancer, we have been recognized as one of the top two cancer hospitals in the country by U.S. News & World Report for more than 30 years.
In compliance with applicable State regulatory authorities, vaccination for COVID-19 and Influenza (flu) is mandatory for all MSK staff who do not work 100% remotely (including new hires ). Staff are considered fully vaccinated upon completion of a primary vaccination series for COVID-19 Exceptions from the COVID-19 vaccine requirement are permitted for those who request and receive an approved medical, religious, or fully remote exemption. Requests for exemption can take up to two weeks to review. Vaccination or an approved medical exemption is required to start work.
Job Description
We are:
We're taking bold steps to redefine what's possible in Laboratory Medicine. Our state-of-the-art clinical laboratories provide sophisticated technology and automated equipment that allow our teams to get to answers faster and more efficiently, with a strong emphasis on applied and translational research. We are committed to the growth and advancement of the department and fully support the active collaboration of scientists, clinicians, and industry experts to develop next-generation laboratory methods. MSK is dedicated to providing diverse educational opportunities to develop further the skills and ambitions of our medical technologists, laboratory managers, and laboratory directors.
It's an exciting time for our Laboratory Medicine Department as many of our teams have recently moved into our new state-of-the-art laboratory medicine facility on East 64th Street. Our new Laboratory Medicine Building maximizes operational efficiency, allowing our Laboratory Medicine team to provide test results more quickly and reduce the amount of blood needed from a patient to generate those results. For further information, please visit: https://www.mskcc.org/departments/laboratory-medicine/expertise
We are seeking a Quality Assurance Specialist in our Cell Therapy laboratory
You Will:
- Provide an objective, independent view of the processes and the execution of established procedures
- Ensure compliance to in-house procedure/workflows, standards, and good manufacturing practices
- Assist the laboratory supervisor(s) and manager, as needed
- Interview the line staff with minimal disruption, and interface and coordinating with all levels of staff including program area management
- Manage the Event Investigation Reports, RISQ reports and associated documentation
- Investigate Cell Therapy events and suggest appropriate corrective and/or preventive actions for implementation
- Manage Change Control Requests, Qualifications and Validations and associated documentation, including audits
- Review Proficiency Testing receipt and result summary and document
- Assist in the initial writing, review, revision, and implementation of the Quality SOPs, including new and revised policies
- Review regulatory documents, to stay abreast of current regulations and trends, ensuring appropriate actions are taken to incorporate necessary revision into workplace environment and maintain Continuing Education as required
- Serve as liaison to other institutional monitoring and audit groups
- Assist the Laboratory Manager, and the Laboratory Director in performing process development analysis for a wide range of internal and external customers
- Assist the Laboratory Manager, and the Laboratory Director in developing the Quality Management System
- Prepare reports and conduct Quality System audits
- Assist in preparing the Cell Therapy Lab for quality audits; and auditing new method validations, preparing formal audit reports and maintaining accreditation with FDA, FACT, AABB, and NYS regulations
- Assist the Laboratory Manager during laboratory inspections and audits
- Review staff competencies in collaboration with the supervisors
- Review Equipment Quality Control in collaboration with the supervisors
- Review final reports associated with validations and analytical test methods
- Ensure compliance with local, state, and federal accrediting and regulatory organizations regarding HPC manufacturing, including compliance with OSHA, FDA, NMDP, Joint Commission, CAP, CLIA, FACT, and AABB
You Need:
- Bachelor's degree in Medical Laboratory Science, Biology or Chemistry
- Licensed in NYS as Clinical Laboratory Technologist
- ASCP license preferred
Hours:
Learn more about our Benefits!
Pay Range $106,500.00-$170,400.00
Please click to learn more about MSK's compensation philosophy.
Closing
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.