Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Performs Quality and technical review of Nonconformance investigations (Company) and CAPAs within defined timeframes.
Ensure investigations and root cause analyses 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 the Quality Systems team as needed to investigate non-conformances and ensure proper implementation of CAPAs.
Prepare monthly and quarterly metrics to present at Quality Review meetings.
These roles are required to support compliance activities at the Plainsboro facility while site personnel are focused on FDA responses.
Requirements:
and non-conformance experience required.
Investigation experience required.
CAPA Managing system.
Bachelor’s Degree is required.
7+ years of experience.
Bach degree required.
Preferred exp in Med Device but not required.
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.