Temporary Quality Specialist, Batch Record Review at Vertex in Boston, MA

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Job Description:

Temporary Contract, 6 Months

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.

Key Leadership Skills:
  • Cross- functional collaborator
  • Results Driver
Key Knowledge/ Skills and Competencies:
  • The ability to thrive in a high throughput environment
  • Communication / Coaching / Influencing
  • Ability to communicate effectively across all organizational levels
  • Critical Thinking / Problem Solving
  • Ability to evaluate quality matters and make decisions utilizing risk based approach
  • Adaptability/Flexibility
  • Attention to detail
  • Knowledge in the following areas:
    • Expert knowledge of global GMP requirements governing Finished Goods and solid working knowledge of GDP requirements
    • Strong knowledge of packaging and labeling process and artwork requirements
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

Qualification:

  • 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

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