Newborn Screening - Laboratory Quality Assurance Specialist

University of Wisconsin Madison•Madison, WI

2d•Onsite

About The Position

The Wisconsin State Laboratory of Hygiene (WSLH), part of the University of Wisconsin-Madison, is hiring a Laboratory Quality Assurance Specialist for the Wisconsin Newborn Screening Program. The role supports the Director and Assistant Director of Newborn Screening by ensuring accuracy, compliance, and safety in newborn screening testing. It focuses on quality control, regulatory compliance, and process improvement, including review and maintenance of training records, standard operating procedures, and other laboratory records in accordance with requirements such as CAP, CLIA, and HIPAA. The position also contributes to proficiency testing and routine short-term follow-up related to specimen quality and newborn screening timeliness. Additional work includes reviewing data, applying statistical analysis tools, monitoring trends, preparing reports, training staff on quality and safety, leading unit audits and risk assessments, and leading projects to ensure quality and consistency. The position operates under the general supervision of the Assistant Director of Newborn Screening. Work is performed at the WSLH Henry Mall location. The position is 100% onsite during initial training; remote work opportunities may be established with the Director after hire and successful completion of training. Routine hours are 8:00 a.m. to 4:30 p.m., Monday through Friday, with rotational holidays and weekends as needed.

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.
Provide an official or copy of an official transcript showing the conferred degree as a condition of employment.
For degrees earned outside the United States, provide proof of qualification equivalency from a nationally recognized organization; course-by-course review is required for candidates demonstrating ability to meet CLIA qualifications.

Nice To Haves

5 years of high-complexity clinical laboratory experience.
3 years of clinical laboratory quality assurance experience.
1 year of molecular testing experience.
1 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 safe, optimal operation and required accreditation documentation.
Prepare, organize, generate, and review laboratory workflows, process improvements, documentation, SOPs, 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 data, apply statistical analysis tools, monitor trends, and prepare reports.
Train staff on quality and safety, and lead unit audits, risk assessment activities, and projects to ensure quality and consistency.