Deviation Investigation Level 3 - Day Shift
Core
Leading complex deviation investigations and driving compliant outcomes within a cGMP environment to prevent recurrence of issues.
Role type
Senior IC Quality Assurance Deviation Investigator
Builds
Investigation reports, CAPAs, and process improvements for biologics manufacturing
Domain
Life Sciences / Biologics Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced root cause analysis (5 Whys, fishbone, cause mapping), CAPA development, cGMP/GDP/data integrity knowledge, technical writing, risk-based decision making, mentoring
Preferred skills
Biologics or mammalian manufacturing process knowledge, Microsoft Office proficiency
Technologies
Microsoft Office (Excel, Word, PowerPoint), Root Cause Analysis tools
Responsibilities
Lead and independently execute complex deviation investigations, Provide technical guidance and strategic direction on investigation approach, Mentor and support Level I and II investigators, Make critical real-time decisions related to deviation containment, Apply advanced root cause analysis tools to drive thorough investigations, Manage moderate to high volumes of concurrent investigations
Seniority
Senior, hands-on IC with mentorship responsibilities