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Senior Quality Assurance Representative

2 months ago

Bloomington, Indiana, United States Catalent Inc Full time

About the Role

The Senior Quality Assurance Representative serves as the primary contact for assigned projects, ensuring seamless collaboration with internal and external stakeholders. This role is responsible for representing Quality Assurance and managing client relationships to sustain and enhance quality performance.

Key Responsibilities

  • Represent Quality Assurance as the primary contact for assigned projects, facilitating cross-functional internal and external collaboration.
  • Interface with clients and manage internal communication to maintain and improve client quality relationships.
  • Produce and maintain metrics related to client quality performance, including complaints, deviations, effectiveness checks, and actions.
  • Provide ad-hoc services to enhance product quality, including risk assessments, kaizen events, and information gathering for critical quality events.
  • Notify clients of major/critical deviations impacting their product within 24 hours.
  • Perform other duties as assigned.

Requirements

  • Bachelor's degree preferred.
  • Minimum 5 years of pharmaceutical manufacturing experience with a bachelor's degree or 8+ years of experience with justification.
  • Minimum 2 years of GxP experience or other regulated industry experience.
  • Ability to read and understand English-written job instructions and safety requirements.
  • Prior experience working with external pharmaceutical clients preferred.
  • Strong working knowledge of quality systems and processes preferred.

Why Catalent

  • Defined career path and annual performance review and feedback process.
  • Medical, dental, and vision benefits effective on first day of employment.
  • Potential for career growth on an expanding team and organization.
  • 152 hours of paid time off annually plus 8 paid holidays.
  • Community engagement and green initiatives.
  • Competitive salary with bonus potential.
  • Tuition reimbursement program.
  • Diverse, inclusive culture.
  • Generous 401K match.