Senior Laboratory QA Specialist – Quality & Compliance

Abbott Laboratories; Phoenix (AZ); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Laboratories in Phoenix, AZ seeks a Sr. Clinical Laboratory QA Specialist to develop, implement, and maintain a quality management system in a regulated clinical lab.

This role ensures regulatory compliance across CAP, CLIA, NY, CA, MD, and FL, and supports continuous improvement with robust metrics and CAPA processes. Responsibilities include monitoring policies, investigations of nonconformances, facilitating audits, and guiding cross‑functional teams on HIPAA requirements while

Qualifications

• Bachelor’s degree in a scientific major or related field with 3+ years in a regulated QA environment.
• Strong understanding of FDA, CLIA, CAP, HIPAA or similar regulatory bodies.
• Proficient with Microsoft Office and ability to learn new software.

Responsibilities

• Monitor and maintain quality policies to meet CAP, CLIA, NY, CA, MD, FL standards.
• Develop lab-based metrics to measure quality system efficacy.
• Investigate nonconformances, perform root cause analysis, implement CAPA.
• Coordinate end-user feedback and documentation for escalations.
• Collaborate with privacy and cross‑department teams on HIPAA compliance.

Skills

Quality assurance

Regulatory compliance

Microsoft Office

FDA/CAP/HIPAA knowledge

HIPAA awareness

Education

Bachelor’s degree in a scientific major or related field

Job description

Abbott Laboratories in Phoenix, AZ seeks a Sr. Clinical Laboratory QA Specialist to develop, implement, and maintain a quality management system in a regulated clinical lab.

This role ensures regulatory compliance across CAP, CLIA, NY, CA, MD, and FL, and supports continuous improvement with robust metrics and CAPA processes. Responsibilities include monitoring policies, investigations of nonconformances, facilitating audits, and guiding cross‑functional teams on HIPAA requirements while