Principal Quality Compliance Specialist Deviations and Client Support

KBI Biopharma•Durham, NC

37d

About The Position

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.

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.

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.
Review and 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 personnel.
Works to streamline these processes.
Supports the generation of metrics, trends and project specific status updates of Deviations and CAPAs.
Notifies the Client of deviations.
Supports external client review and resolution of comments for assigned deviations and related CAPAs as needed.
Attend relevant operational and project meetings.
Support client audits and regulatory inspections as required.