Senior QA Specialist Deviations and CAPAs

QA Compliance Specialist

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. 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. Review and approve Deviations and CAPAs. Facilitates triage meetings, performing classifications of DTRs. 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.

Attends relevant operational and project meetings. Support client audits and regulatory inspections as required. Provides training for Deviation and CAPA TRNs to KBI staff. Supports the generation of metrics, trends and project specific status updates of Deviations and CAPAs.

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.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.