Principal/sr. Associate-qa-api External Manufacturing

Eli Lilly UK

Indianapolis, Indiana, US
Base: $65,250 - $169,400; bonus/equity: compyny bo...
Quality oversight of contract manufacturing organizations
Compliance to cgmp and regulatory requirements
Batch evaluation and disposition
The API EM Quality Assurance Consultant ensures all batches meet specifications and comply with validated processes and regulatory commitments

Job Summary

  • The API EM Quality Assurance Consultant ensures all batches meet specifications and comply with validated processes and regulatory commitments.
  • The role involves serving as a liaison between contract manufacturers and Lilly, providing quality oversight and participating in regulatory inspections.
  • Lilly offers a comprehensive benefits program, including bonuses, 401(k), pension, medical and wellness benefits, and supports diversity and inclusion through employee resource groups.

Matching Summary

The API EM Quality Assurance Consultant ensures all batches meet specifications and comply with validated processes and regulatory commitments.

Salary

Base: $65,250 - $169,400; Bonus/Equity: Company bonus eligibility based on performance; Benefits: Comprehensive benefits including 401(k), pension, medical, dental, vision, and wellness programs

Skills & Requirements

Must-have

  • Quality oversight of contract manufacturing organizations
  • Compliance to cGMP and regulatory requirements
  • Batch evaluation and disposition
  • Regulatory inspection support
  • Quality agreement management
  • API manufacturing quality support

Nice-to-have

  • Coaching and mentoring skills
  • Root cause analysis experience
  • Statistical skills application
  • Strong written and verbal communication
  • Interpersonal and networking skills
  • Ability to prioritize multiple tasks
  • Influence and relationship management

Key Requirements

  • Bachelor’s degree in science-related field
  • 2+ years GMP manufacturing experience in API or pharma
  • Authorized to work full-time in the United States

Work Rights

Authorized to work full-time in the United States

Tailored Resume

Cover Letter