Principal Quality Compliance Specialist Deviations and Client Support

Job description

Job Summary: Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations and other functional groups as required (e.g. Facilities Engineering, IT, Supply Chain, etc.). Support timely review of events for classification, initiation in EtQ and closure. Mentors junior QA staff in deviation/CAPA review and approval to include training and certification of QA approvers. Provide metrics to management as requested. Job Responsibilities: - 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. Reviewand approve Deviations and CAPAs. Classifies deviations and assists in leading daily triage meetings. - Works directly with manufacturing, facilities, and other departments responsible for GMP activities to support resolution of deviations and other compliance issues in a timely manner in support of batch release activities. Provides training for Deviation and CAPA TRNs to KBI staff. - Collaborate with functional areas to improve the Deviation/CAPA system to include support in development of training materials and training person...