Deviation Investigation Level 2 - Night Shift
Core
Leading and executing deviation investigations within a cGMP environment to identify root causes and implement corrective and preventive actions (CAPAs).
Role type
Senior IC Quality Assurance Deviation Investigator
Builds
Compliant investigation reports and effective CAPAs for biologics and mammalian processes
Domain
Life Sciences / Biologics Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis (5 Whys, fishbone, cause mapping), CAPA development, cGMP/GDP compliance, technical writing, cross-functional collaboration, mentoring
Preferred skills
Biologics or mammalian process experience, Microsoft Office proficiency
Technologies
Microsoft Office (Excel, Word, PowerPoint)
Responsibilities
Lead minor deviation investigations independently, support major deviation investigations, mentor Level I investigators, make real-time containment decisions, manage concurrent investigations, develop and implement CAPAs, maintain compliance with cGMP/GDP/data integrity standards
Seniority
Senior, hands-on IC with mentorship responsibilities