Newborn Screening - Laboratory Quality Assurance Specialist

University of Wisconsin; Madison (WI); Sur place; USD 63 000 - 77 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package

Generous paid time off

Health/dental/vision/life insurance

Wisconsin Retirement System (WRS)

Résumé du poste

The Wisconsin State Laboratory of Hygiene – part of the University of Wisconsin–Madison – seeks a Laboratory Quality Assurance Specialist for the Newborn Screening program. This on-site role focuses on quality control, regulatory compliance (CAP/CLIA/HIPAA), and process improvements to ensure timely and accurate newborn screens.

Responsibilities include data analysis, training staff, audits, and maintaining training records and SOPs.

Qualifications

• Minimum of 2 years high-complexity clinical laboratory experience; 5 years preferred.
• Minimum of 1 year clinical laboratory QA experience; 3 years preferred.
• Regulatory knowledge of CLIA, CAP, and HIPAA.
• Strong data analysis and documentation skills precede inspection and audits.

Responsabilités

• Coordinate quality assurance activities to ensure accuracy and safety in newborn screening.
• Review equipment calibration and preventive maintenance records for compliance.
• Develop and review SOPs, QA/QC test records, and training materials.
• Lead unit audits, risk assessments, and process improvement projects.

Connaissances

Attention to detail

Data interpretation

Technical writing

Communication skills

Formation

Bachelor degree in chemical/biological/clinical laboratory science

Description du poste

Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process.

Job Category:

Academic Staff

Employment Type:

Regular

Job Profile:

Laboratory Quality Assurance Specialist

Job Summary:

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.

Key Job Responsibilities:

• 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%

• Assures the review of equipment calibration and preventive maintenance records to ensure optimal, safe operation and accreditation documentation requirements are met - 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%

• 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%

• Creates and updates training materials and monitors staff compliance with established accreditation requirements and laboratory best practices - 15%

• Administrative responsibilities, including: proficiency testing documentation and routine report of quality control data to NBS management - 10%

• 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%

Department:

Wisconsin State Laboratory of Hygiene – Disease Prevention Division – Newborn Screening

Compensation:

Minimum Salary is: $70,000/year.

• Depending on the experience of a successful candidate, the position will pay according to the salary administration guidelines.
• Actual pay is determined at hire and is based on experience and qualifications.
• This position offers a comprehensive benefits package, including generous paid time off, competitively priced health/dental/vision/life insurance, tax-advantaged savings accounts, and participation in the Wisconsin Retirement System (WRS) pension fund. For a summary of benefits, please see http://www.wisconsin.edu/ohrwd/benefits/download/fasl.pdf.

Required Qualifications:

The WSLH is certified through the Clinical Laboratory Improvement Act (CLIA), and accredited by the College of American Pathologists (CAP).

Laboratory Quality Assurance Specialist:

Minimum of 2 years high-complexity clinical laboratory experience required; 5 years high-complexity clinical laboratory experience is preferred.

Minimum of 1 year of clinical laboratory quality assurance experience; 3 years of clinical laboratory quality assurance experience preferred.

Regulatory Knowledge: Advanced understanding of CLIA, CAP, and HIPAA requirements.

Skills: Exceptional attention to detail, strong data interpretation, clear technical writing, and effective communication skills.

Preferred Qualifications:

1 year of molecular testing experience; preferred

1 year of mass spectrometry testing experience; preferred

Education:

At minimum, a Bachelor degree in a chemical, biological, clinical laboratory science, medical technology from an accredited institution, is required.

An official (or copy of an official) transcript showing conferred degree will be required as a condition of employment.

For degrees earned outside of the United States, proof of qualification equivalency is required and must be performed by a nationally recognized organization such as the National Association Credential Evaluation Services, Inc. (NACES) (http://www.naces.org) or the Association of International Credential Evaluators, Inc. (http://www.aice-eval.org). Course by course review is required for candidates demonstrating ability to meet CLIA qualifications.

The candidate is responsible for all expenses related to acquiring and providing proof of qualifications.

WSLH does not sponsor work visas at the time of hire or anytime during employment for this position. All persons hired will be required to verify identity and eligibility to work in the United States and complete the required Employment Eligibility Form I-9.

The selected applicant will be required to pass a criminal background check prior to an offer of employment.

Contact Information:

Please contact Kelsey Bailey, [e-mail] with questions.

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

The University of Wisconsin-Madison is an Equal OpportunityEmployer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgroundsand encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website.

To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you.

Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.