Principal - Qa Api External Manufacturing Peptides

Eli Lilly

Indianapolis, IN, US
Base: $65,250 - $169,400; bonus/equity: eligible f...
Bachelor's degree in chemistry or related field
5 years qa experience in pharmaceutical industry
Strong knowledge of cgmp regulations fda ema
This role provides essential Quality Assurance oversight for API External Manufacturing operations ensuring compliance with cGMP and regulatory requirements

Job Summary

  • This role provides essential Quality Assurance oversight for API External Manufacturing operations ensuring compliance with cGMP and regulatory requirements.
  • The position involves leading batch record reviews, conducting quality audits of external sites, and managing deviations and change controls.
  • Lilly offers a comprehensive benefit program including medical, dental, vision, 401(k), pension, and flexible spending accounts.

Matching Summary

This role provides essential Quality Assurance oversight for API External Manufacturing operations ensuring compliance with cGMP and regulatory requirements.

Salary

Base: $65,250 - $169,400; Bonus/Equity: Eligible for company bonus based on performance; Benefits: Comprehensive program including 401(k), pension, medical, dental, vision

Skills & Requirements

Must-have

  • Bachelor's degree in Chemistry or related field
  • 5 years QA experience in pharmaceutical industry
  • Strong knowledge of cGMP regulations FDA EMA
  • Experience auditing external manufacturing sites
  • Proficiency with quality management systems like Veeva

Nice-to-have

  • API manufacturing process understanding
  • Excellent problem-solving and critical thinking skills
  • Ability to work independently in fast-paced environment
  • Strong communication skills for diverse audiences

Key Requirements

  • Bachelor's degree in Chemistry Biochemistry Pharmacy or Chemical Engineering
  • Minimum 5 years QA experience in pharmaceutical/biopharma
  • Authorized to work in the United States full-time
  • No visa sponsorship provided by employer

Work Rights

Must be authorized to work in the US on a full-time basis

Tailored Resume

Cover Letter