Newborn Screening - Laboratory Quality Assurance Specialist

Universities of Wisconsin•Madison, WI

4d•$70,000•Onsite

About The Position

The Wisconsin State Laboratory of Hygiene (WSLH), part of the University of Wisconsin-Madison, is hiring a full-time Laboratory Quality Assurance Specialist for the Wisconsin Newborn Screening Program. The position supports the Director and Assistant Director of Newborn Screening by ensuring the accuracy, regulatory compliance, and safety of newborn screening testing at WSLH. It maintains quality control, supports regulatory requirements, and drives process improvements through inspections, audits, and quality assurance work. This includes reviewing and maintaining training records, standard operating procedures, and laboratory records to meet policy and regulatory requirements, including CAP, CLIA, and HIPAA. The specialist also contributes to proficiency testing and routine short-term follow-up activities related to specimen quality and newborn screening timeliness. The position reviews data, applies statistical analysis tools, monitors trends, prepares reports, trains staff on quality and safety, leads unit audits and risk assessments, and leads projects to support quality and consistency. It works under the general supervision of the Assistant Director of Newborn Screening. Duties are performed at the WSLH Henry Mall location. Routine hours are 8:00 a.m. to 4:30 p.m., Monday through Friday, with rotational holidays and weekends as needed. The role is 100% onsite during initial training; remote-work opportunities may be established with the Director after hire and successful completion of training.

Requirements

At least 2 years of high-complexity clinical laboratory experience.
At least 1 year of clinical laboratory quality assurance experience.
Advanced understanding of CLIA, CAP, and HIPAA requirements.
Exceptional attention to detail, strong data interpretation, clear technical writing, and effective communication skills.
At least a bachelor's degree in chemical, biological, clinical laboratory science, or medical technology from an accredited institution.
An official or copy of an official transcript showing the conferred degree is required as a condition of employment.
For degrees earned outside the United States, proof of qualification equivalency from a nationally recognized organization is required; course-by-course review is required for candidates demonstrating ability to meet CLIA qualifications. The candidate is responsible for related expenses.

Nice To Haves

Five years of high-complexity clinical laboratory experience.
Three years of clinical laboratory quality assurance experience.
One year of molecular testing experience.
One year of mass spectrometry testing experience.

Responsibilities

Serve as a main point of contact for organizational leadership and accreditation agencies, provide project information, and update and maintain a portion of a project-specific budget.
Review equipment calibration and preventive maintenance records to ensure equipment operates optimally and safely and accreditation documentation requirements are met.
Prepare, organize, generate, and review laboratory workflows, process improvements, documentation, standard operating procedures, and QA/QC test records.
Collect quality metrics and communicate with healthcare providers to help ensure eligible newborns receive a valid newborn screen, focusing on specimen quality and screening timeliness.
Perform internal and external laboratory audits as needed and respond to audit requests to ensure compliance with regulatory and technical requirements.
Create and update training materials and monitor staff compliance with accreditation requirements and laboratory best practices.
Document proficiency testing and routinely report quality-control data to Newborn Screening management.
Evaluate laboratory workflows and procedures, including occurrence management processing and documentation; recommend continuous quality improvements and ensure laboratory accreditation requirements are met.
Review and maintain training records, standard operating procedures, and other laboratory records for compliance with policies and regulatory requirements.
Support routine short-term follow-up activities related to specimen quality and newborn screening timeliness.
Review data, use statistical analysis tools, monitor trends, and prepare reports.
Train staff on quality and safety, and lead unit audits, risk assessments, and projects to ensure quality and consistency.