Quality Assurance Specialist

2 weeks ago


Boston Massachusetts, United States Vertex Pharmaceuticals Full time
Job Summary

The Quality Assurance Specialist - Archive Management will be responsible for performing multiple activities in support of their group or clients under minimal supervision. The Specialist will apply technical proficiency and attention to detail in troubleshooting, as well as the ability to interpret and execute project plans and lead initiatives with minimal guidance.

Key Responsibilities
  • Presents a solid understanding of quality assurance concepts and practices
  • Demonstrates knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts related to document control
  • Responsible for all GxP Archiving Activities and regulatory knowledge
  • Presents a solid understanding of both digital and paper document control best practices
  • Exercises independent judgment to optimize compliance procedures and identify opportunities for continuous improvement
  • Able to manage and anticipate client expectations
  • Displays effective communication skills (written and verbal), within their area(s) of expertise
  • Demonstrates proactive thinking and actions
  • Responsible for reviewing and authoring SOPs and Work Instructions, with minimal supervision
  • Acts as a representative of their Quality division on assigned project sub-teams and/or task forces
  • Demonstrates proficiency in influencing others within project teams regarding quality or compliance concerns
  • Displays an ability to develop innovative ideas for solving problems
  • Displays solid organizational and project management skills
  • Has the ability to read and respond to audiences appropriately
Requirements
  • 3-5 years experience in QA and archive management
  • Experience in Biotech or Pharmaceutical industry


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