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.

• 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.

• DNA

• Cell isolation

• Microscopy (Cell counting)

• 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.

• Trains, directs, assigns duties to, and may supervise lab employees in quality assurance-related tasks.

Perform other duties as assigned.

• 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.

• 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.

• Experience with maintaining accreditation with ASHI/CLIA/CAP or similar agency and 1 year of work experience in Quality Assurance and/or compliance.