QC Lead Investigator

Job Summary

A company is looking for a QC Lead Investigator, Lab Equipment.

Key Responsibilities:

• Conduct comprehensive laboratory equipment investigations and quality incident reviews in compliance with cGMP and FDA regulations
• Perform root cause analysis and implement Corrective and Preventive Actions (CAPAs) to resolve quality events
• Collaborate with cross-functional teams to investigate equipment issues and ensure timely resolution of deviations

Required Qualifications:

• Bachelor's degree in a scientific field with 3-5+ years of experience, or a Master's degree with 2+ years in QC, QA, or analytical laboratories within a GMP-regulated environment
• Strong knowledge of FDA, ISO, and cGMP regulations
• Experience with laboratory equipment investigations and troubleshooting analytical instruments
• Proven experience with CAPA identification, root cause analysis, and change control management
• Familiarity with laboratory equipment software and data systems such as Empower and LabX