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Change Control Specialist

2 months ago


Troy, New York, United States Regeneron Pharmaceuticals Full time
Job Summary

We are seeking a highly skilled Change Control Specialist to join our team at Regeneron Pharmaceuticals. As a key member of our quality assurance team, you will be responsible for developing and implementing strategic plans to ensure compliance with regulatory requirements and industry standards.

Key Responsibilities
  • Develop and implement change control plans to ensure compliance with regulatory requirements and industry standards
  • Assess and evaluate proposed changes to ensure they meet company standards and regulatory requirements
  • Coordinate and prepare change control documentation, including risk assessments and impact analyses
  • Review and revise controlled documentation to ensure accuracy and compliance
  • Lead cross-functional meetings to drive change control implementation and provide guidance to cross-functional teams
  • Monitor and progress multiple projects concurrently, identifying and addressing potential obstacles
  • Present business-critical change controls to senior leadership and document all training
Requirements
  • Bachelor's degree in Life Sciences, Engineering, or related field
  • Minimum 2+ years of relevant experience in quality assurance or regulatory compliance
  • Strong attention to detail and organizational skills
  • Excellent technical writing and interpersonal communication skills
  • Ability to work in a fast-paced environment and manage multiple assignments and changing priorities
What We Offer

Regeneron Pharmaceuticals offers a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees. We are an equal opportunity employer and welcome applications from diverse candidates.