Lead Clinical Lab QA Specialist

About the job

• 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.
• JOB DESCRIPTION:
• Working at Abbott
• At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
This position works out of our Madison, WI location supporting Quality Assurance in the Cancer Diagnostic Division.

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions.  We help people live full and healthy lives through our accessible, molecular-based solutions.

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.
• 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.

• 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.

JOB FAMILY:
Quality Assurance
DIVISION:
ONCO Cancer Diagnostics
LOCATION:
United States > Madison : 1 Exact Lane
ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
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