Investigation Lead II
Core
Lead quality investigations from intake through completion, evaluating evidence to determine root causes and recommend corrective and preventive actions (CAPAs) to ensure product quality and regulatory compliance.
Role type
Senior IC Quality Investigation Lead
Builds
Inspection-ready investigation reports and CAPA recommendations
Domain
Pharmaceutical/Medical Device Manufacturing Quality
Required skills
Root cause analysis, CAPA development, risk assessment, technical writing, project management, data integrity knowledge, eQMS proficiency, hypothesis testing, cross-functional collaboration
Preferred skills
Regulatory inspection support, structured problem-solving methodologies (5 Whys, Fishbone, DMAIC), statistical analysis tools, Lean Six Sigma Green Belt, ASQ certification
Technologies
TrackWise, Microsoft Office
Responsibilities
Lead quality investigations from intake through completion; Analyze evidence from manufacturing records, lab data, and interviews; Develop and test hypotheses to identify root causes; Partner with cross-functional experts to align on findings; Assess product, process, and patient impacts; Recommend CAPAs with measurable effectiveness indicators; Author inspection-ready investigation reports.
Seniority
Senior, hands-on IC