Principal/sr. Associate-qa-apiem

Lilly

$65,250 - $169,400; bonus/equity: compyny bonus; b...
Quality oversight of contract manufacturing organizations
Ensure batches meet specifications
Cgmp and regulatory compliance
The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs), ensuring all batches meet specifications and are compliant to cGMPs and regulatory commitments

Job Summary

  • The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs), ensuring all batches meet specifications and are compliant to cGMPs and regulatory commitments.
  • Key responsibilities include serving as a liaison between CMs and Lilly, providing quality oversight, escalating quality issues, and assisting in the establishment and revision of Quality Agreements.
  • Lilly offers a comprehensive benefit program including 401(k), pension, vacation, medical, dental, vision, life insurance, and well-being benefits.

Matching Summary

The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs), ensuring all batches meet specifications and are compliant to cGMPs and regulatory commitments.

Salary

$65,250 - $169,400; Bonus/Equity: Company bonus; Benefits: Comprehensive benefit program

Skills & Requirements

Must-have

  • Quality oversight of Contract Manufacturing Organizations
  • Ensure batches meet specifications
  • cGMP and regulatory compliance
  • API shipments quality coordination
  • Regulatory inspection preparation
  • Evaluate and disposition API batches

Nice-to-have

  • Coaching and mentoring skills
  • Root cause analysis experience
  • Statistical skills application
  • Strong attention to detail
  • Interpersonal and networking skills
  • Influence diverse groups

Key Requirements

  • Bachelors degree in science-related field
  • 2+ years GMP manufacturing experience
  • Authorized to work in the United States

Work Rights

Must be authorized to work in the United States

Tailored Resume

Cover Letter