Katalyst Healthcares and Life Sciences
Responsibilities:
- Performs Quality and technical review of Nonconformance investigations (Company) and CAPAs within defined timeframes. Ensures investigations and root cause analysis are accurate and complete.
- Maintain an accurate log of Non-Conformances and CAPAs activities. Tracks, follows-up and assists in the timely closure of Company/CAPAs.
- Provides hands-on guidance and training to all personnel performing activities within the Quality system.
- Ensure documentation is complete before closure.
- Assist Quality Systems team as needed to investigate Nonconformances and ensure proper implementation of CAPAs.
- Prepare monthly and quarterly metrics to present at Quality Review meetings.
- Bachelor's Degree is required. 7+ years of experience.
- Monitors, inspects, and evaluates products to ensure predetermined quality standards are met. Develops and updates testing-related documentation, including test cases, plans, and flaw-reporting procedures.
- These roles are required to support compliance activities at the Plainsboro facility while site personnel are focused on FDA responses.
- CAPA and nonconformance experience required.
- Investigation experience required.
- Managing system.
- 6-7 years' experience.