Specialist Manufacturing – Drug Product Investigation Support
Core
Support the Drug Product Manufacturing Investigation Team by coordinating, executing, and tracking minor and major manufacturing deviation investigations to ensure compliance with quality and regulatory requirements.
Role type
Specialist Manufacturing – Drug Product Investigation Support
Builds
compliant manufacturing operations and deviation resolution for biologic drug products
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
client delivery (internal manufacturing operations)
Required skills
deviation investigation management, root cause analysis, CAPA development, cross-functional coordination, electronic quality management systems, GMP regulations knowledge, data collection, trend analysis, documentation, project coordination
Preferred skills
GMP manufacturing experience, quality systems experience, investigation support, tracking quality records, technical documentation, cross-functional matrix environment navigation
Technologies
electronic quality management systems
Responsibilities
Execute and track minor and major manufacturing deviation investigations; gather information and document findings for investigation owners; manage scheduling and prioritization of deviations; coordinate cross-functional activities with Manufacturing, Quality Assurance, and Engineering; support inspection and audit readiness activities; develop and maintain deviation metrics and reports; escalate timeline risks
Seniority
Specialist, hands-on IC