Laboratory Quality Specialist -Transplant Center (Senior Research Technologist)

Job Summary

The Laboratory Quality Specialist supports and maintains all regulatory and accreditation standards related to laboratory quality management under the supervision of the clinical and research transplant laboratories' leadership.

Technical Specific Responsibilities

• Provides QA leadership and support to the transplant laboratory and biorepository, ensuring quality and compliance procedures are followed.
• Aids in planning and participating in preparedness activities in support of regulatory inspections.
• Maintains best practice standards, identifies potential training needs, and optimizes resource utilization.
• Leads monthly Quality Assurance meetings, delegates monthly QA activities, and prepares QA reports and documentation.
• Collaborates in laboratory process validations, tracks quality of laboratory instrumentation and reagents, and ensures preventative maintenance is scheduled and performed.
• Recognizes areas to improve laboratory service to clinical and research programs and ensures employees are up-to-date on training, continuing education, and competency observation requirements.
• Coordinates multiple complex quality lab projects and stays updated on regulatory requirements and guidance.
• Participates in internal self-inspections/audits and may participate in external audits in support of ASHI or CAP.

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 appropriate combination of education and experience.
• At least 5 years' lab/bench or other relevant experience.
• 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 field, or appropriate combination of education and experience.
• At least 3 years' lab/bench or other relevant experience.

Minimum Competencies

• Demonstrated laboratory experience serving in the capacity as a project leader.
• Proficient in lab processes and quality monitoring.
• Exceptional communication skills, ability to work with a wide range of colleagues, vendors, etc., and strong attention to detail.
• Strong organizational, planning, decision-making, and facilitation skills.
• Strong knowledge of Microsoft Excel.

Preferred Qualifications

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

Professional Growth & Development

Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

Benefits

Northwestern offers comprehensive 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; generous retirement savings options; and wellness programs. Visit https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life & Wellness

Northwestern supports flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Equal Opportunity Employer

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.