QA/QMS Senior Specialist — Deviations & Investigations
Nivagen Pharmaceuticals, Sacramento, CA 95834 +1
What you will do
- Own the deviation lifecycle from initiation through investigation, root cause analysis, corrective action identification, and closure within established timelines.
- Serve as the primary point of contact for all deviation-related activities across Manufacturing, Quality Control, Engineering, and Validation departments.
- Conduct thorough root cause analyses using structured methodologies including Ishikawa (6M), 5-Why, and fault tree analysis.
- Author investigation narratives, initial quality assessments (IQAs), and final deviation reports in TrackWise.
- Classify deviations by severity (Critical, Major, Minor) and assess impact on product quality, patient safety, validated state, and regulatory compliance.
- Coordinate batch disposition activities in collaboration with QA batch release and QC laboratory teams.
- Identify recurring deviation trends and escalate to the CAPA system when systematic issues are identified.