Sr. Clinical Laboratory 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.

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 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

Include but are not limited to the following:

• 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 inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.

Minimum Qualifications

• Bachelor's degree in a scientific major or related field and 3+ years of experience in quality assurance in a regulated environment; or high school degree/general education diploma with 4+ years of relevant experience working within a quality management system in a regulated environment and 3+ years of experience in quality assurance in a regulated environment.
• Demonstrated understanding and professional working knowledge of FDA, CLIA, CAP, HIPAA, or other regulatory body.
• Proficient in Microsoft Office programs.
• Demonstrated aptitude for learning new software.
• 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.
• Experience with or demonstrated understanding of specific state regulatory requirements for clinical laboratory operations, such as California, New York, Maryland, or Florida.
• Experience with audits or inspections by regulatory bodies, such as CAP, NY, or FDA.
• Experience in a quality assurance role in a regulated environment.
• Additional certifications in Six Sigma or quality assurance.

The base pay for this position is $78,000.00 - $156,000.00. In specific locations, the pay range may vary from the range posted.