Investigation Specialist
Core
Investigate non-conformances in manufacturing operations, analyze trends, and implement corrective actions to ensure cGMP compliance.
Role type
Investigation Specialist (Quality/Technical Operations)
Builds
Robust corrective actions and compliant manufacturing processes
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
cGMP compliance knowledge, root cause analysis, report writing, data trending, batch record review, SOP management, cross-functional collaboration
Preferred skills
Experience in deviation investigation, knowledge of manufacturing processes
Responsibilities
Independently investigate non-conformances, prepare investigation reports with recommendations, analyze and summarize investigation data, review batch records and logbooks, edit controlled documents, monitor production processes, lead cross-functional study teams, gather and trend process data
Seniority
Mid-level (2+ years experience)