Principal Quality Assurance Reviewer
Core
Review and approve compliance investigations (non-conformances, OOS/OOT, supplier actions) and provide quality oversight for manufacturing operations in a Fill Finish facility.
Role type
Principal Quality Assurance Specialist/Reviewer
Builds
Robust corrective actions and quality systems for sterile drug product manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Investigation leadership, cGMP compliance, data analysis, cross-functional coordination, training, process monitoring
Preferred skills
Sterile drug product manufacturing experience, Fill Finish expertise, Quality Control testing background
Technologies
None explicitly stated
Responsibilities
Independently review and approve investigations into non-conformances and proposed corrective actions; Analyze and summarize trends in investigation reports; Present quality recommendations to management; Review primary data sources for accuracy per cGMP; Monitor production processes and quality systems data; Lead cross-functional study teams; Train employees on investigative processes
Seniority
Principal, hands-on IC with strategic oversight