Lead Clinical Lab QA Specialist

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

     

• Bachelor’s degree in a scientific major or field related to the essential duties of the position.
• 4+ years of professional work experience in quality assurance in a regulated environment.

• 3+ years of experience developing, establishing, and implementing quality indicators within a laboratory environment.

• 2+ years of direct experience leading process and project implementation, management, or improvement.

• 2+ years of experience managing, monitoring, and maintaining Quality Management Systems (QMS).
• Demonstrated experience leading quality management meetings with senior leadership, including gathering, analyzing, and presenting key quality metrics, performance indicators, and supporting data to drive discussions and continuous improvement initiatives.

• Demonstrated understanding and professional working knowledge of FDA, CLIA, CAP, HIPAA, or other applicable regulatory entities and standards.
• Proficient in Epic healthcare software or other electronic patient medical record (ePHI) software/system.
• Proficient in Microsoft Office programs.
• Demonstrated aptitude for learning new processes and software.
• Demonstrated ability to collaborate across functions with both internal and external stakeholders, and to communicate ideas and opinion in a proactive and professional manner.
• Exceptional written and verbal communication skills, excellent attention to detail and organization skills.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

• Advanced degree in a scientific field related to the essential duties of the position.
• Experience with (or demonstrated understanding of) specific state regulatory requirements for clinical laboratory operations, such as CA, NY, MD, and FL.
• Experience with audits or inspections by regulatory bodies, such as CAP, FDA, and/or NY State Department of Health.
• Additional quality assurance or project management certifications such as Six Sigma or PMP.
• Experience developing and maintaining quality indicators, KPIs, dashboards, or quality performance reporting in a clinical laboratory, healthcare, diagnostic, or regulated environment.
• Strong data analysis and interpretation skills, including identifying trends, emerging risks, recurring issues, and opportunities for continuous improvement.
• Experience investigating nonconformances and adverse quality trends, including root cause analysis, CAPA, and effectiveness monitoring.
• Demonstrated ability to facilitate quality reviews and communicate complex quality data into clear, actionable insights for leadership and cross-functional stakeholders.
• Proven ability to collaborate and lead through influence across functions, driving alignment, accountability, and resolution of quality-related issues.

 

     

$86,700.00 – $173,300.00

In specific locations, the pay range may vary from the range posted.

     

Quality Assurance

     

ONCO Cancer Diagnostics

        

United States > Madison : 1 Exact Lane

     

Standard

     

No

     

Not Applicable

     

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf