Quality Specialist, Batch Record Review
Top Technical Skills:
- Batch Record Review
- TrackWise and QDocs
The Quality Specialist works with a high degree of independence to ensure compliance with applicable regulatory requirements. The Quality Specialist completes work in a resourceful, self-sufficient manner. They are responsible for specific pieces of moderately complex projects and may work on multiple projects.
- Performs Drug Product batch disposition activities upon review of executed batch records and certificate of analysis for commercial products
- Provides quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
- Facilitates continuous improvement efforts to improve CMO batch release metrics as needed
- Collaborates cross-functionally to integrate activities with other groups, departments and project teams as needed
- Models Core Values and leadership behaviorsand fosters their demonstration in others
- Experience with commercial batch release activities, with proficient knowledge of the following in a pharmaceutical setting:
- cGMP’ s and associated CMC regulatory considerations
- Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with network-based applications such as Oracle and TrackWise preferred.