- Thousand Oaks, California, United States
- $108K–$146K per year
- 2+ years
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 107,545.40USD -145,502.60 USD
Responsibilities
- Own, manage, and close quality records (Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations, Corrective and Preventive Actions (CAPAs), and CAPA-Effectiveness Verifications) under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
- Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance or timely implementation of supplier/raw material related changes.
- Partner cross-functionally across the network to ensure maturity and execution of robust quality record process.
- Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.).
- Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV).
Requirements
- Doctorate degree
- Master’s degree
- Bachelor’s degree
- Associate’s degree