Research Laboratory Quality Systems Specialist

Hiring Department

Life Sciences Center

The Wan Influenza Systems Biology Laboratory seeks a highly motivated Research Laboratory Quality Systems Specialist to lead the development, implementation, oversight, maintenance, and continuous improvement of laboratory quality systems supporting research in influenza and emerging infectious diseases.

The successful candidate will collaborate closely with the Principal Investigator, staff scientists, laboratory personnel, and operational managers to establish standardized laboratory practices, enhance research reproducibility, ensure data integrity, and maintain compliance with institutional policies, sponsor requirements, and laboratory quality standards.

Serving as the laboratory’s quality lead, this position is responsible for developing and managing the laboratory Quality Management System (QMS), quality assurance programs, documentation systems, data integrity initiatives, and continuous quality improvement efforts. The Quality Systems Manager works closely with the Program Manager, Laboratory Manager, Sample Operations and Inventory Manager, Automation Engineer, Human Study Coordinator, Animal Study Coordinator, and research personnel to ensure research activities are conducted using standardized, well-documented, and reproducible processes.

• Develop, implement, maintain, and continuously improve the laboratory Quality Management System (QMS) in alignment with laboratory best practices, ISO/IEC 17025 principles, NAHLN guidelines, institutional policies, and sponsor requirements. Responsibilities include SOP lifecycle management, document control, records management, quality documentation, metric development, and process improvement initiatives.
• Plan and conduct internal quality audits; coordinate external assessments; and lead corrective and preventive action (CAPA) programs, nonconformance investigations, root cause analyses, risk assessments, and continuous quality improvement activities.
• Develop and oversee laboratory data quality and integrity programs by establishing quality control procedures, monitoring data completeness and consistency, performing quality analyses using R and/or Python, and creating dashboards that support research reproducibility, operational excellence, and data-driven decision-making.
• Monitor sample quality documentation, chain-of-custody records, metadata completeness, protocol adherence, and quality checkpoints throughout the sample lifecycle using laboratory information management systems (e.g., Shiny Lab). Collaborate with laboratory leadership and research personnel to identify, investigate, and resolve quality issues that may affect research integrity.
• Conduct periodic reviews of laboratory notebooks, electronic laboratory records, metadata, and supporting research documentation to verify completeness, traceability, compliance with SOPs, and data integrity. Partner with investigators, study coordinators, and regulatory personnel to ensure documentation supporting IRB, IBC, IACUC, biosafety, and sponsor requirements is complete, consistent, and audit-ready. This position provides quality oversight and documentation review but does not serve as the primary owner of regulatory submissions.
• Develop and deliver training programs for laboratory personnel on quality systems, SOP implementation, documentation standards, laboratory best practices, data integrity, research reproducibility, and continuous improvement methodologies. Foster a culture of quality, accountability, consistency, and continuous learning throughout the laboratory.
• Prepare quality metrics, management review reports, audit summaries, performance indicators, and quality improvement recommendations to support laboratory leadership, sponsor reporting, accreditation efforts, and strategic decision-making.

Monday-Friday, 8am-5pm

A Bachelor''s degree or an equivalent combination of education and relevant experience and at least 3 years of experience from which comparable knowledge and skills can be acquired is necessary.

• Working knowledge of ISO/IEC 17025 quality management principles, AAVLD/NAHLN quality requirements, and research compliance processes.
• Experience performing data quality control, validation, and analysis using R and/or Python.
• Demonstrated ability to manage multiple projects and timelines while effectively communicating with principal investigators, collaborators, regulatory agencies, and other stakeholders.
• Familiarity with biosafety, biosecurity, and regulatory compliance requirements in a research or laboratory environment.
• Experience developing, maintaining, or supporting Quality Management Systems (QMS), including quality documentation and compliance activities.
• Knowledge of corrective and preventive actions (CAPA), change control, deviation investigations, risk assessments, and continuous improvement methodologies.
• Experience preparing quality metrics, annual quality reports,…