Newborn Screening - Laboratory Quality Assurance Specialist

University of Wisconsin Madison•Madison, WI

2d•Onsite

About The Position

The Wisconsin State Laboratory of Hygiene (WSLH) is the state's public and environmental health laboratory. As part of the University of Wisconsin-Madison, the WSLH is committed to exploring new ideas which benefit the state, the nation and the world. Join our vital public health mission as a full-time, on-site Laboratory Quality Assurance Specialist for the Wisconsin Newborn Screening Program. The primary role of this position is to assist the Director and Assistant Director of Newborn Screening by ensuring accuracy, compliance, and safety for the newborn screening testing conducted at the WSLH. This role focuses on maintaining quality control, upholding regulatory requirements, and driving process improvements through various newborn screening-related inspection, auditing and quality assurance capacities, including review and maintenance of training records, standard operating procedures and other laboratory records to ensure compliance with policy and regulatory requirements (including but not limited to CAP, CLIA, and HIPAA). In addition, this position will play an active role in the laboratory’s proficiency testing activities and supports routine short-term follow-up activities that are related to specimen quality and NBS timeliness as part of the overall newborn screening laboratory quality assurance program. Additional key responsibilities of this position include: review of data, application of statistical analysis tools, monitoring of trends, preparing reports, training staff on quality and safety, leading unit audits and risk assessment activities, leading projects to ensure quality and consistency. This position performs under the general supervision of the Assistant Director of Newborn Screening. Duties for this position are performed onsite at the WSLH Henry Mall location. Routine work hours are 8:00am – 4:30pm Monday-Friday. Rotational Holidays and weekends as needed. This position will be 100% onsite for initial training. Remote working opportunities will be established with the Director upon hire and successful completion of training.

Requirements

Minimum of 2 years high-complexity clinical laboratory experience required
Minimum of 1 year of clinical laboratory quality assurance experience
Advanced understanding of CLIA, CAP, and HIPAA guidelines.
Exceptional attention to detail, strong data interpretation, clear technical writing, and effective communication skills.
At minimum, a Bachelor degree in a chemical, biological, clinical laboratory science, medical technology from an accredited institution, is required.
Applicants must meet CLIA qualification requirements for § 493.1461 General Supervisor, High Complexity Testing Laboratory Quality Assurance Specialist.

Nice To Haves

5 years high-complexity clinical laboratory experience is preferred.
3 years of clinical laboratory quality assurance experience preferred.
1 year of molecular testing experience
preferred 1 year of mass spectrometry testing experience

Responsibilities

Creates and updates training materials and monitors staff compliance with established accreditation requirements and laboratory best practices - 15%
Collect quality metrics and communicate with healthcare providers to ensure that all eligible newborns are provided a valid newborn screen, with a focus on specimen quality and NBS timeliness - 10%
Performs internal and external laboratory audits as needed and responds to audit requests to ensure compliance with regulatory and technical requirements - 10%
Serves as a main point of contact to organizational leadership and accreditation agencies, provides project information, and updates and maintains a portion of a project-specific budget - 5%
Prepares, organizes, generates, and reviews laboratory workflows and process improvement, documentation, Standard Operating Procedures (SOPs), and quality assurance/quality control (QA/QC) test records - 30%
Assures the review of equipment calibration and preventive maintenance records to ensure optimal, safe operation and accreditation documentation requirements are met - 5%
Assists with the evaluation of laboratory workflows and procedures including occurrence management processing and documentation. Makes recommendations for continuous quality improvement and assures laboratory accreditation requirements are met - 15%
Administrative responsibilities, including: proficiency testing documentation and routine report of quality control data to NBS management - 10%