Laboratory Quality Specialist -Transplant Center (Senior Research Technologist)

Department: MED-Transplant Center
Salary/Grade: NEX/15

Target hiring range for this position will be between be range is as be $31.31-$33.82 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.

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.

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 is required.

Molecular Biology:

• DNA

Cellular Biology:

• Cell isolation

Histology:

• Microscopy (Cell counting)

Administration

• 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 and summarizes lab expenses, as assigned.
• Verifies accuracy of invoices.

• Orders and/or maintains inventory of reagent, and/or lab supplies, as needed

Supervision

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

Miscellaneous

Perform other duties as assigned

Minimum Qualifications: (Education, experience, and any other certifications or clearances)

• 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: (Education and experience)

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

Preferred Competencies: (Skills, knowledge, and abilities)

• Demonstrates sense of ownership and leadership; focused on goal and accomplishments.
• 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 working 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 are proud to provide meaningful and competitive benefits. The available benefits package for this position will include 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; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html 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. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.