Quality Specialist, Batch Record Review

Boston, MA

Posted: 05/08/2019 Employment Type: Contract Industry: Life Sciences Job Number: 229341

Top Technical Skills:
  • Batch Record Review
  • TrackWise and QDocs

Job Description:

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

Minimum Qualifications:
  • 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.
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