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.

     

 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.

• 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.

• 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.

     

$78,000.00 – $156,000.00

In specific locations, the pay range may vary from the range posted.

     

Operations Quality

     

ONCO Cancer Diagnostics

        

United States > Phoenix : 200 E Van Buren St

     

Standard

     

No

     

No

     

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