Senior / Principal Associate Qa Api External Manufacturing

Eli Lilly

Base: $65,250 - $169,400; bonus: compyny bonus eli...
Not specified
Cgmp regulations knowledge
Api manufacturing experience
External site auditing
Eli Lilly is seeking a Senior/Principal Associate QA API External Manufacturing professional to ensure quality and compliance in externally manufactured Active Pharmaceutical Ingredients (APIs). The ideal candidate will possess extensive experience in Quality Assurance within the pharmaceutical industry, specifically in API manufacturing, and will have strong collaboration skills to work with external manufacturing partners

Job Summary

  • This role serves as the primary Quality Assurance point of contact for externally manufactured Active Pharmaceutical Ingredients (APIs) to ensure cGMP compliance.
  • The position requires leading quality audits of external partners and overseeing critical quality events such as deviations and investigations.
  • Eli Lilly offers a comprehensive benefit program including medical, dental, vision, 401(k), pension, and flexible spending accounts.

Matching Summary

Match Score: 85

Eli Lilly is seeking a Senior/Principal Associate QA API External Manufacturing professional to ensure quality and compliance in externally manufactured Active Pharmaceutical Ingredients (APIs). The ideal candidate will possess extensive experience in Quality Assurance within the pharmaceutical industry, specifically in API manufacturing, and will have strong collaboration skills to work with external manufacturing partners.

Salary

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

Skills & Requirements

Must-have

  • cGMP regulations knowledge
  • API manufacturing experience
  • external site auditing
  • deviation investigation management
  • CAPA execution

Nice-to-have

  • cross-functional collaboration skills
  • negotiation abilities
  • international travel capability
  • additional language skills
  • continuous improvement mindset

Key Requirements

  • Bachelor's degree in Chemistry, Pharmacy, or Chemical Engineering
  • 5-8 years QA experience in pharmaceutical industry
  • In-depth knowledge of ICH Q7 and 21 CFR Part 210/211
  • Ability to travel up to 25% domestically and internationally

Work Rights

Not specified

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