Senior Clinical Lab QA Specialist - Quality Assurance Lead

Regulatory Jobs; Phoenix (AZ); Vor Ort; USD 78.000 - 156.000; Vollzeit

Benefits dieser Stelle

Medical coverage

Retirement plan

Tuition reimbursement

Education programs

Zusammenfassung

Abbott seeks a Sr. Clinical Laboratory QA Specialist in the Cancer Diagnostics division in Phoenix, AZ. The role drives quality management, regulatory compliance, and continuous improvement across laboratory operations.

You will monitor systems, lead audits, and guide investigations while ensuring patient data protection and cross‑functional collaboration to support Abbott’s diagnostic capabilities.

Qualifikationen

• Bachelor's degree in a scientific field or related area.
• 3+ years of QA experience in a regulated environment (FDA/CAP/CLIA/HIPAA).
• Proven ability to monitor quality systems and implement CAP/CLIA requirements.
• Strong communication and documentation skills.

Aufgaben

• Develop and maintain quality management system to meet regulatory standards.
• Monitor effectiveness of quality processes and drive continuous improvement.
• Lead internal audits and investigations; coordinate corrective/preventive actions.
• Review patient records and ensure HIPAA compliance.
• Collaborate with privacy office and cross-functional teams.

Kenntnisse

Quality Assurance

Regulatory Compliance

Document Control

Cross-functional Collaboration

Ausbildung

Bachelor's degree in a scientific field

Tools

Microsoft Office

Jobbeschreibung

Abbott seeks a Sr. Clinical Laboratory QA Specialist in the Cancer Diagnostics division in Phoenix, AZ. The role drives quality management, regulatory compliance, and continuous improvement across laboratory operations.

You will monitor systems, lead audits, and guide investigations while ensuring patient data protection and cross‑functional collaboration to support Abbott’s diagnostic capabilities.