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Quality Specialist (Boston, MA)

Key Responsibilities:

  • 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 Vertex Core Values and leadership behaviors and 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.
  • M.S (or equivalent degree) and 0-3 years of relevant work experience, or
  • B.S in scientific or allied health field (or equivalent degree) and 3-6 years of relevant work experience

Sthree US is acting as an Employment Business in relation to this vacancy.