Investigations Specialist
Core
Conduct root cause analyses and investigations to identify and implement Corrective and Preventative Actions (CAPAs) for site deviations in pharmaceutical manufacturing.
Role type
Senior IC Quality Investigations Specialist
Builds
Quality improvements, reduced repeat deviations, and waste reduction in production environments
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, CAPA implementation, Six Sigma tools (Fishbone, 5 Whys), Change Control management, Project management, Data analysis, Regulatory inspection preparation, Stakeholder communication
Preferred skills
Sterile manufacturing experience, Process Validation, Lean Six Sigma certification, TrackWise QMS proficiency
Technologies
MiniTab, Microsoft Office, TrackWise
Responsibilities
Lead complex investigations and create project plans for timely closure; Serve as an Operations technical SME in cross-functional Method 1 (M1) investigations; Utilize Six Sigma tools for root cause identification; Drive timely closure and quality improvements to reduce repeat deviations; Proactively engage with Operations staff to identify CI initiatives; Initiate and deliver Change Controls related to CAPAs; Present investigation findings during Regulatory inspections and audits; Monitor and report deviation performance metrics.
Seniority
Mid-Senior, hands-on IC
