QO Investigations Coordinator 503B
Core
Coordinate quality investigations, maintain records, and drive corrective actions for deviations and non-conformances in a 503B outsourcing facility.
Role type
Quality Operations Coordinator (Investigations)
Builds
Investigation documentation, CAPA tracking, and quality metrics for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
dashboards & analysis
Required skills
Quality investigation practices, cGMP requirements, USP <795>/<797>/<800> standards, data collection, root cause analysis, CAPA tracking, record maintenance, Microsoft Excel/Word proficiency
Preferred skills
Experience with deviations/non-conformances, CQIA certification
Technologies
Microsoft Excel, Microsoft Word, investigation tracking systems
Responsibilities
Collect and organize investigation data for deviations and non-conformances; Conduct initial event assessments and document facts; Draft investigation documentation summarizing evidence and conclusions; Track corrective and preventive action commitments and due dates; Maintain complete investigation records and supporting documentation; Compile investigation metrics and trending reports to identify recurring issues
Seniority
Mid-level, hands-on IC
