Sr. Clinical Laboratory QA Specialist
Job Location:
Phoenix, NM - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Working atAbbott
AtAbbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for freemedical coveragein ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution.
Tuition reimbursement theFreedom 2 Savestudent debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelors 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.
Were 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 Abbotts 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 worlds greatest healthcare challenges.
Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to lifes 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 companys 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
Bachelors 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
$78000.00 $156000.00In specific locations the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Senior IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
