Lead Clinical Lab QA Specialist

American Society for Quality; Madison, Northern (WI, KY); Hybrid; USD 87,000 - 173,000; Full time

Job summary

Abbott is seeking a Lead Clinical Lab QA Specialist to develop, implement, and maintain the Quality Management System for the Exact Sciences Laboratories, ensuring compliance with FDA, CLIA, CAP, HIPAA, and other regulatory requirements. The role focuses on monitoring system effectiveness, supporting continuous improvement, and educating workforce on procedures and regulations.

You will independently manage multiple cross-functional projects, provide SME guidance to QA teams and lab sites,

Qualifications

• Bachelor’s degree in a scientific major.
• 4+ years of QA experience in a regulated environment.
• 2+ years leading process and project implementation.
• Knowledge of FDA, CLIA, CAP, HIPAA, or other regulations.
• Proficient in Epic or other ePHI software.
• Proficient in Microsoft Office programs.
• Ability to collaborate across functions and communicate professionally.
• Excellent written and verbal communication; detail-oriented.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Independently manage multiple, complex projects with defined timelines.
• Identify, develop, design, and coordinate improvements.
• Provide SME guidance to Lab QA teams and sites.
• Investigate, document, and resolve quality assurance concerns.
• Lead cross-functional projects with internal and external partners.
• Interface professionally with all levels of the organization and vendors.
• Work in a team environment and adapt to change.
• Uphold Quality Management System policies and procedures.
• Travel between work locations.

Skills

Quality assurance experience

Regulatory knowledge

Cross-functional collaboration

Attention to detail

Professional communication

Education

Bachelor’s degree in a scientific field

Tools

Epic software

Microsoft Office

Job description

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 115,000 colleagues serve people in more than 160 countries.

Position Overview
The Lead Clinical Lab QA Specialist is responsible for the development, implementation, administration, and maintenance of the Quality Management System for the Exact Sciences Laboratories. This role is also responsible for ensuring compliance with all clinical laboratory regulatory requirements. The Lead Clinical Lab QA Specialist will monitor the effectiveness of the quality management system, identify, support, and facilitate continuous improvement opportunities and educate the workforce on applicable procedures and regulations.

Essential Duties
Include, but are not limited to, the following:

• Independently manage multiple, complex projects simultaneously within defined timelines, prioritizing as necessary, with minimal instruction or oversight.

• Identify, develop, design, and assist with coordinating improvements.

• Provide subject matter expertise, guidance, and recommendations to Lab QA team members and other Exact Sciences Lab teams/sites while leading through influence, informal leadership, and best practice advocacy.

• Investigate, document, and resolve complex quality assurance related concerns received from various lab teams, enterprise teams, and 3rd party vendors.

• Utilize project management experience to initiate and lead cross-functional projects with both internal and external partners.

• Ability to interface, work effectively, and conduct themselves in the highest professional manner with all levels of the organization, vendors, customers, etc.

• Ability to work in a team environment and adapt to and embrace change in projects, workload, and circumstances effectively; able to respond to new information quickly.

• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

• Support and comply with the company’s Quality Management System policies and procedures.

• Maintain regular and reliable attendance.

• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.

• Ability and means to travel between work locations.

• Ability to maintain confidential information.

Minimum Qualifications

• 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.

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

• 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.

Preferred Qualifications

• 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.

The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.