Cell Therapy Quality Spec

Job DescriptionLocation: Chicago, ILHospital: RUSH University Medical CenterDepartment: Rush Univ Cancer Center MSPWork Type: Full Time (Total FTE between 0.9 and 1.0)Shift: Shift 1Work Schedule: 8 Hr (8:00:00 AM - 5:00:00 PM)Summary:Are you a dedicated healthcare professional seeking a shift from direct patient care to a role where your expertise can make a different kind of impact? As a Cell Therapy Quality Specialist, you’ll be part of the BMT Quality Team working with the BMT Quality Manager, CPL Director, BMT Medical Director and other staff to maintain regulatory and quality requirements for the Cell Processing Laboratory. This role allows you to leverage your clinical knowledge in a new way, focusing on ensuring the highest quality and regulatory compliance for life-saving products and procedures. Primary responsibilities of this position include quality management for products, reagents, and equipment to meet standards and satisfy regulatory requirements (FACT, CAP, FDA, JCAHO). By maintaining rigorous standards and contributing to continuous improvement efforts, you'll be part of a team that upholds Rush's mission and values while making a significant difference in patient outcomes behind the scenes.In this position, you’ll have the opportunity to build unique skills in quality management, regulatory compliance, and process improvement, expanding your expertise beyond traditional bedside care. You'll engage in high-level activities such as conducting audits, conducting root cause analysis, and managing the activities of the quality plan. This role provides valuable experience in a specialized field and contributes to transformative patient care in a behind-the-scenes position that supports and enhances patient care.Other information:Required Job Qualifications: Bachelor’s degree in a related field . Minimum of three years of experience in cellular therapy or related field. Extreme attention to detail and strong analytical ability are required to ensure accuracy of data. Advanced knowledge of cell processing and aseptic techniques, basic knowledge of immunology, cell biology, hematology, and blood banking. Experience operating in a regulated environment including familiarity with cGMP/cGTP standards, internal and external audits, and good documentation practices. Familiarity with proper and safe operation and maintenance of basic and complex lab equipment including centrifuges, biosafety cabinets, LN2 freezers and controlled rate freezers. Experience with controlled documents including authoring and editing standard operating procedures, occurrence reports and validation protocols. Experience with technical transfer and development of new laboratory processes and procedures. Advanced MS Office skills including creating and modifying documents, using, and programming spreadsheets and databases, and the ability to quickly adopt and use new software. Effective time management and organizational skills; able to appropriately prioritize, delegate and/or execute multiple tasks simultaneously. Strong interpersonal skills; ability to work independently and as a collaborative team member. Ability to serve as both the technical leader in the cellular therapy laboratory and resource for BMT staff and management when questions or problems arise. Strong understanding of the regulatory and quality requirements applicable to cellular therapy and deep knowledge of and the ability to embody good laboratory and good documentation practices. Problem-solving skills for very complex problems that may quickly arise and require investigation and initiative to reach a final resolution. Process, apply and communicate specialized scientific and technical knowledge critical to managing irreplaceable products essential for patients.Preferred Job Qualifications: Preferred experience in healthcare related to laboratory, pharmacy, nursing, or other health discipline. Graduate degree in a health care-related field preferred.Disclaimer: The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.Responsibilities: Have an active role in preparing, reviewing, modifying, approving and/or implementing quality management policies and procedures and will ensure that procedures are in compliance with FACT Standards, FDA regulations, Joint Commission, and all state and governmental laws and regulations before implementation in the Processing Facility. Maintain systems to review, modify, and approve cell processing lab policies and procedures intended to monitor compliance with FACT Standards and the performance of the and Processing Facilities. Perform internal audits, assessments, and corrective action plans to ensure compliance with the written SOPs, policies, and procedures. Assist with preparation for external audits. Assist with management of Occurrence Reports, reporting of deviations to the FDA concerning all procured, processed, or transplanted HPCs as needed. Collaborate with Quality Manager to develop and review the quality assurance plan with appropriate monitors. Assist with the summary of these monitors Provide reports and analysis for regular Quality Improvement meetings. Facilitate and assist in process improvement initiatives. Assist with and complete necessary change control processes. Perform environmental monitoring of the laboratory. Responding to REES alarm system and correcting the controlled parameters if necessary. Coordinate the management of and validation process for changes/updates to the LIS and other software applications used in the cell processing lab. Annually validate product labeling software updates In collaboration with the Quality Manager, develop and oversee a plan to assure continual accreditation readiness Handling other related tasks as necessaryRush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.Position Cell Therapy Quality SpecLocation US:IL:ChicagoReq ID 7369