Sr. Clinical Laboratory QA Specialist

Abbott; Phoenix (AZ); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan

Tuition reimbursement

Job summary

Abbott in Phoenix, AZ is seeking a Sr. Clinical Laboratory QA Specialist to lead quality management activities within the Cancer Diagnostic Division.

The role focuses on implementing and maintaining a compliant quality system across CAP/CLIA and state standards, while driving continuous improvement and regulatory education for staff. The position requires strong leadership, collaboration across functions, and meticulous documentation to ensure patient safety and data integrity.

Qualifications

• Develop and maintain a quality management system compliant with CAP/CLIA and state regulations.
• Monitor effectiveness of the quality system and drive continuous improvement.
• Educate workforce on relevant procedures and HIPAA requirements.

Responsibilities

• Continuously monitor and maintain policies to meet CAP/CLIA and state standards.
• Develop laboratory metrics to measure quality system efficacy.
• Review nonconforming events, perform root cause analysis, and implement corrective actions.
• Provide assessment and guidance for end-user feedback; coordinate reports for escalations.
• Review and maintain patient medical records.
• Ensure training and awareness of HIPAA and data protection across the lab.
• Support internal audits/investigations and quality system readiness.
• Lead process improvement projects and document results.
• Communicate ideas professionally across functions.

Skills

Leadership

Communication

Collaboration

Documentation

Decision-making

Attention to detail

Job description

Working at Abbott

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.

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 Phoenix, AZ location 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 Sr. Clinical Laboratory QA Specialist is responsible for many quality aspects in the clinical laboratory including developing, implementing, and maintaining a quality management system, ensuring compliance with all regulatory requirements. The Sr. Clinical Laboratory QA Specialist will monitor effectiveness of the quality management system, identify, support, and facilitate continuous improvement opportunities, and educate the workforce on applicable procedures and regulations.

Essential Duties

• Continuously monitor and maintain policies and procedures to ensure the clinical laboratory meets respective standards and regulations, such as CAP, CLIA, New York, California, Maryland, and Florida.
• Develop laboratory-based metrics to measure efficacy of the quality system and provide visibility for management oversight
• Review and document nonconforming events, conduct investigations, perform root cause analysis, and develop and implement corrective and preventive actions.
• Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback; coordinate processes, reports, and documentation for escalations arising from feedback.
• Review, investigate, evaluate, and maintain patient medical records.
• Work with the privacy office and cross-departmental staff to provide guidance and awareness of health insurance portability and accountability act (HIPAA), protection of patient data, pertinent regulations and requirements, and relevant quality system policies and procedures.
• Ensure quality system robustness and laboratory readiness through assisting with internal audits/investigations.
• Project management for process creations, improvement, and harmonization. - Apply exceptional written and verbal communication skills.
• Strong attention to detail, organization, and record-keeping skills.
• Ability to collaborate across functions and with both internal and external stakeholders.
• Strong leadership and decision-making skills.
• Ability to communicate ideas, opinions, and counter arguments in a proactive and professional manner.
• 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 act with an inc