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Form of workDepartment: MED-Transplant Center Salary/Grade: NEX/15 Job Summary: Under the general supervision of the clinical and research transplant laboratories' leadership, the Laboratory Quality Specialist is responsible for supporting and maintaining all regulatory and accreditation standards (CLIA, ASHI, CAP, OPTN/UNOS) related to Laboratory Quality management. They will champion various aspects of the Quality Management Program, such as tracking and investigating non-conforming events, and facilitating their resolution with guidance of the laboratory leadership. The specialist will ensure compliance with regulatory requirements, monitor any potential changes to these requirements that may affect laboratory operations, and harmonize practices amongst all the transplant laboratory groups.
Employee will require access to NM/Northwestern Memorial Hospital and Lurie Children's Hospital. Employee affiliation to NM requires yearly influenza vaccination documentation submission or proof of accommodation/ religious/medical exemption. Target hiring range for this position will be between $27.50-$32.84 per hour.
Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. per hour Specific Responsibilities: Technical The position will be responsible for providing QA leadership and support to the transplant laboratory and biorepository, ensuring quality and compliance procedures are followed across the laboratories in support of ASHI/CLIA and CAP accreditation and OPTN/UNOS regulatory compliance. Aids in planning and participates in preparedness activities in support of regulatory inspections.
Regularly meets with the laboratory management team in the development of best practice standards, identifying potential training needs and optimization of resource utilization. Leads monthly Quality Assurance meetings, delegates monthly QA activities to team members. Identifies assay problems through observation, compilation, and trending of laboratory data, and recommends problem solving based on root cause analysis.
Works closely with section supervisors (Flow, Molecular, Intake, and Biorepository) and helps coordinate Quality Assurance activities, including the preparation of QA reports and documentation. Collaborates in laboratory process validations. Tracks quality of laboratory instrumentation and reagents, assists section supervisors to ensure that preventative maintenance is scheduled and performed per regulations.
Recognizes areas to improve laboratory service to the clinical and research programs. Ensures employees are up to date on training, continuing education, and competency observation requirements. Assists in design, development, and management of QA program databases; compiles & analyzes data; prepares reports.
Coordinates multiple complex quality lab projects. Stays up to date on regulatory requirements and guidance (CAP, CLIA, OSHA, HIPAA, etc.). Participates in internal self-inspections/audits and may participate in external audits in support of ASHI or CAP.
Laboratory experience demonstrating good judgment, conscientiousness, precision and accuracy and a fully functioning level of understanding of the stated skills below: Molecular Biology: DNA Cellular Biology: Cell Isolation Histology: Microscopy (Cell Counting) Administrative Oversees and manages lab databases which may include observing other employees to ensure that 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 that these are accessible to the laboratory teams. Finance Tracks & summarizes lab supply expenses. Verifies accuracy of invoices.
Orders &/or maintains inventory of reagent, &/or lab supplies. Supervises Trains, directs, assigns duties to, and may supervise lab EEs in quality assurance-related tasks Miscellaneous Performs 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; OR appropriate combination of education and experience and 5 years' lab/bench or other relevant experience required; OR Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a scientific major or related; OR appropriate combination of education and experience and 3 years' lab/bench or other relevant experience.
Minimum Competencies: (Skills, knowledge, and abilities.) At least 2 years of demonstrated laboratory experience serving in the capacity as a project leader. Must be proficient in lab processes and quality monitoring. Exceptional communication skills, able to work with full spectrum of colleagues, vendors, etc.
Strong attention to detail Strong skills for 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 work experience in Quality Assurance and/or compliance. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.
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More information can be found on the COVID-19 and Campus Updates webpage. The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Click for information on EEO is the Law.
