Senior Quality Assurance Specialist

2 days ago


Durham, North Carolina, United States KBI BioPharma Full time
Job Summary

This Quality Assurance Specialist position collaborates with cross-functional teams to ensure compliance with cGMP requirements and company SOPs. The role is responsible for reviewing and approving Deviations, CAPAs, and Effectiveness Checks, as well as providing support for timely review of events for classification, initiation in EtQ, and closure.

The individual in this position will write Deviation investigations and provide metrics to management as requested. They will also mentor QA staff in deviation/CAPA review and approval, including training and certification of QA approvers.

The position participates on cross-functional teams that regularly collaborate to improve the Deviation/CAPA system, supports development of training materials and training personnel, and supports Audits and Regulatory Inspections as required.

Key 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.
  • Reviews and approves Deviations and CAPAs.
  • Provides training for Deviation and CAPA TRNs to KBI staff.
  • Collaborates with functional areas to improve the Deviation/CAPA system, including support in development of training materials and training personnel.
  • Supports the generation of metrics, trends, and project-specific status updates of Deviations and CAPAs.
  • Attends relevant operational and project meetings.
  • Supports client audits and regulatory inspections as required.
Minimum Requirements

Minimum BS in a 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, including Batch Record review, supporting investigations, and CAPAs.

Knowledge of US, EU, and ROW cGMP guidelines required.



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