Laboratory Quality Specialist -Transplant Center (Senior Research Technologist)

Job Summary Department: MED-Transplant Center Location: Chicago, Illinois Salary/Grade: NEX/15 The position is a Laboratory Quality Specialist responsible for supporting and maintaining all regulatory and accreditation standards (CLIA, ASHI, CAP, OPTN/UNOS) related to laboratory quality management. The role champions various aspects of the Quality Management Program, including tracking and investigating non-conforming events and facilitating resolution with guidance from laboratory leadership. It ensures compliance with regulatory requirements, monitors potential changes to these requirements, and harmonizes practices among all transplant laboratory groups. Specific Responsibilities Provide QA leadership and support to the transplant laboratory and biorepository, ensuring quality and compliance procedures across laboratories in support of ASHI/CLIA and CAP accreditation and OPTN/UNOS regulatory compliance. Aid in planning and participation in preparedness activities for regulatory inspections. Regularly meet with the laboratory management team to develop best practice standards, identify training needs, and optimize resource utilization. Lead monthly Quality Assurance meetings and delegate monthly QA activities to team members. Identify assay problems through observation, data compilation, and trending; recommend problem solving based on root cause analysis. Work closely with section supervisors (Flow, Molecular, Intake, Biorepository) to coordinate QA activities, including QA reports and documentation. Collaborate in laboratory process validations. Track quality of laboratory instrumentation and reagents; assist supervision to ensure preventative maintenance is scheduled and performed per regulations. Recognize areas to improve laboratory service to clinical and research programs. Ensure employees are up to date on training, continuing education, and competency observation requirements. Assist in design, development, and management of QA program databases; compile and analyze data; prepare reports. Coordinate multiple complex quality lab projects. Stay up to date on regulatory requirements and guidance (CAP, CLIA, OSHA, HIPAA, etc.). Participate in internal self-inspections/audits and external audits in support of ASHI or CAP. Laboratory experience demonstrating good judgment, conscientiousness, precision and accuracy; fully functioning understanding of required skills. Molecular Biology DNA Cellular Biology Cell isolation Histology Microscopy (Cell counting) Administration Oversees and manages lab databases and ensures data is collected and entered correctly. Reviews and analyzes QA data. Updates, reviews, and maintains the laboratories’ quality assurance manuals and other quality documents; ensures accessibility to laboratory teams. Tracks and summarizes lab expenses, as assigned. Verifies accuracy of invoices. Orders and/or maintains inventory of reagents and lab supplies, as needed. Supervision Trains, directs, assigns duties to, and may supervise lab employees in quality assurance-related tasks. Miscellaneous Perform other duties as assigned. Minimum Qualifications Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor’s or higher degree in a scientific major or related field; OR an appropriate combination of education and experience with 5 years of lab/bench or other relevant experience; OR Successful completion of a master’s or higher degree in a scientific major or related field; OR an appropriate combination of education and experience with 3 years of lab/bench or other relevant experience. Minimum Competencies At least 2 years of demonstrated laboratory experience serving as a project leader; proficient in lab processes and quality monitoring. Exceptional communication skills; able to work with colleagues, vendors, etc. Strong attention to detail. Strong skills in organization, planning, decision-making, and facilitating process improvement. Strong knowledge of Microsoft Excel. Preferred Qualifications Experience with maintaining accreditation with ASHI/CLIA/CAP or similar agency and 1 year of work experience in Quality Assurance and/or compliance. Preferred Competencies Demonstrates ownership and leadership; focused on goals and outcomes. High proficiency in computer systems. Ability to create and maintain trend charts supporting monitoring and measuring laboratory performance. Extremely detail-oriented and committed to high quality. Experience in a fast-paced laboratory environment. Hands-on experience with MediaLab. Audit experience and certification is a plus, such as ASQ or Six Sigma. Benefits At Northwestern, we provide meaningful and competitive benefits, including health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; retirement savings options; and wellness programs. For a comprehensive overview of benefits, see the Northwestern benefits page at the Northwestern University site. Work-Life and Wellness Northwestern offers programs and services to help navigate life’s challenges and opportunities and to adopt healthy lifestyles. We support flexible work arrangements where possible and programs to help locate and pay for quality childcare and senior/adult care. Professional Growth & Development Northwestern supports employee career development in all circumstances, whether on campus or remote. Visit the Northwestern learning page to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. Applicants may request accommodations in the application process by contacting the Office of Civil Rights and Title IX Compliance. For more information on accommodations, visit the Northwestern accommodations page. #J-18808-Ljbffr Northwestern University