QC Planner at Vertex in Boston, MA

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Job Description:

This role provides coordination and planning of all testing activities of Release and Stability Laboratory department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible to ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.

Key Responsibilities:
  • Generates testing schedule for the lab and has the ability to evaluate and communicate any changes
  • Coordinates and facilities activities which lead to meeting established turn-around-times
  • Provides oversight and scheduling of all testing activities to ensure testing completed on-time
  • Creates and maintains a capacity tool for RSL. Resolves capacity constraints in RSL scheduling based on consolidated scheduling priorities
  • Develops priorities based on demand requirements, considering resource constraints
  • Ability to formulate solutions/options for team and align externally with key stake holders
  • Interfaces with customers and provides analysis lead times and communicate testing related delays
  • May author and review SOPs
  • Monitor, track and publish performance metrics.
  • Proactively pursues continual improvement opportunities to increase value and efficiency.
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Qualification:

  • A minimum of a Bachelor Degree in science or related discipline is required.
  • 4+ years of experience in pharmaceutical/biopharmaceutical laboratory with 2+ years in production/QC/project planning role.
  • Must have strong organizational skills and the ability to work as part of a team
  • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
  • Effective communication skills, both verbal and written.
  • Basic knowledge of US and EU cGMP regulations/guidance.

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