KBI
Senior QA Specialist Deviations and CAPAs
USA - NC - Durham - Hamlin Rd · Senior
Sponsorship not specifiedDetected 30 days ago
GMP
About the role
- Mentors junior QA staff in deviation/CAPA review and approval to include training and certification of QA approvers.
- Provide metrics to management as requested.
- Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.
Responsibilities
- Collaborates with functional areas to improve the Deviation/CAPA system to include support in development of training materials and training personnel. Works to streamline these processes.
- Supports the generation of metrics, trends and project specific status updates of Deviations and CAPAs
- Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations.
- Support timely review of events for classification, initiation in EtQ and closure.
- Support external client review and resolution of comments for assigned deviations and CAPAs as needed.
Requirements
- Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
- Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs.
- Knowledge of US, EU and Row cGMP guidelines required.
- Support client audits and regulatory inspections as required.
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.