Memorial Sloan-Kettering Cancer Center QA Coordinator - Cell Therapy and Cell Engineering Facility 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.
TheQA Coordinatorassists the QA Manager and the Facility Manager to coordinate and facilitate clinical production and ensure operations throughout the Cell Therapy and Cell Engineering Facility are in compliance with GMP and FDA approved guidelines.
Prepare Batch Production Control Records (BPCRs) for clinical production and assist in the revision of Master Production Control Records (MPCRs)
Coordinate with clinical investigators and clinical supporting staff for clinical production, patient treatment, and sample collection and processing
Ensure test samples and bioassays are procured and conducted in a timely and compliant manner according to guidelines
Implement and monitor QA programs for quarantining and releasing clinical products and samples
Supervise the work of QA Document Specialists, QC Facility Technicians and Material Specialists.
Oversee the databases of clinical products, samples, and reagents such as MCB
Generate Incident Reports, Deviation Reports, Change Controls and CAPA reports
Review GMP procedures for applicability to clinical operations (e.g., requirements for cleaning/operating lab equipment; clinical specimens handling, packaging, transportation, storage), and participate in revision of the procedures
Participate in performing GMP audits of manufacturing, QC and development operations
Provide GMP training for QA and QC staff as well as other staff (i.e., lab operations, building services, outside contractors), as required, maintain the training module
Help develop plans and programs to ensure efficient, effective and compliant operations of the facility
Help implement and maintain SOPs, calibration documents, validation and process development protocols and reports as well as deviations according to GMP and FDA approved guidelines
Help prepare the facility for validation testing and FDA audit/inspections
Help schedule and maximize clinical productions in the facility
Maintain and enhances professional growth and development through seminars, workshops, professional affiliations to keep apprised of all FDA regulations related to GMP and biosafety procedures.
Perform proficiency testing and prepare required reports
BS in biological science with minimum of 10 years or MS with minimum of 7 years hands-on experience in QA/QC in a cGMP environment, interacting with regulatory agencies.
Computer software proficiency required (e.g. Microsoft Word, Excel, PowerPoint, Project, Access, PhotoShop etc).
Able to perform under fast-paced environment, attention to details, good personal skills.
Previous supervisory experience highly desired.
Pharmaceutical industry experience in biologics, or experience in cell and gene therapy is plus.
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 - Other