Quality Investigator
Core
Perform quality assurance investigations to ensure regulatory compliance, investigate customer complaints, and determine product disposition.
Role type
Quality Investigator (cGMP)
Builds
Investigative reports, corrective actions, and product disposition decisions
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, GMP knowledge, complaint investigation, CAPA development, regulatory compliance, product disposition, database management, critical thinking, written reporting
Preferred skills
Knowledge of pharmaceutical packaging records and processes, experience with ERP systems, ability to work independently
Responsibilities
Conduct quality assurance investigations ensuring adherence to GMP regulations, produce written reports summarizing investigations and root cause determinations, investigate customer complaints and maintain records, collaborate with production/QA to minimize downtime, assist in developing corrective actions, determine appropriate disposition of affected product, maintain investigation/CAPA databases, verify effectiveness of corrective actions
Seniority
Mid-level, hands-on IC
