RCA Specialist

Job Summary

A company is looking for an RCA Specialist to manage deviation investigations and quality events in a remote contract position.

Key Responsibilities

• Lead end-to-end deviation investigations including data review, gap identification, root cause analysis, and closure in Veeva EQMS
• Review investigation packages to ensure sufficient supporting data justifies conclusions and identify incomplete investigations
• Collaborate within a small remote unit, adapting responsibilities between initiating investigations, writing, and closing based on workload

Required Qualifications

• 4 to 7 years of GMP quality assurance experience, preferably in biopharma manufacturing
• Hands-on experience writing and closing deviations and CAPAs in a regulated commercial manufacturing environment
• Exposure to sterile injectable or aseptic processing is a plus
• Proficiency or familiarity with Veeva EQMS
• Ability to work independently with minimal ramp-up time