Principal/sr. Associate-qa-apiem

Lilly

Indianapolis, Indiana, USA
$65,250 - $169,400; bonus/equity: compyny bonus; b...
Quality oversight of contract manufacturing organizations
Cgmp compliance
Api batch disposition
The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs), ensuring batches meet specifications and comply with cGMPs

Job Summary

  • The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs), ensuring batches meet specifications and comply with cGMPs.
  • Key responsibilities include serving as a liaison between CMs and Lilly, providing quality oversight, and participating in regulatory inspection preparations.
  • 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 batches meet specifications and comply with cGMPs.

Salary

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

Skills & Requirements

Must-have

  • Quality oversight of Contract Manufacturing Organizations
  • cGMP compliance
  • API batch disposition
  • Regulatory inspection support
  • Quality Agreements management

Nice-to-have

  • Coaching and mentoring skills
  • Root cause analysis experience
  • Statistical skills application
  • Interpersonal and networking skills
  • Ability to influence diverse groups

Key Requirements

  • Bachelors degree in a 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