Laboratory Quality Specialist III

Job Summary

As a fully remote Laboratory Quality Specialist III, the successful candidate will lead complex quality investigations, evaluate laboratory processes, and implement corrective and preventive actions (CAPAs) to ensure compliance with CAP and CLIA accreditation standards while supporting the Global Central Laboratory operations.

Key responsibilities

• Lead complex quality investigations to identify root causes of laboratory quality events and implement corrective actions
• Collaborate with cross-functional teams to develop and monitor the effectiveness of CAPAs and ensure adherence to quality standards
• Provide technical guidance and training to junior staff on investigation methodologies and quality documentation practices

Required qualifications

• Advanced degree plus 3 years of experience, or Bachelor's degree plus 5 years of experience in quality assurance, laboratory operations, or a related field
• Experience in conducting complex quality investigations and performing root cause analysis
• Familiarity with CAPA development and implementation, as well as change control processes
• Experience in regulated laboratory environments such as CAP, CLIA, GLP, or GMP
• Proficiency with laboratory databases and quality management systems, such as TrackWise or Preclarus