Sr. Quality Assurance - Engineer

Lilly

Carolina, PR
Base: $52,500 - $154,000; bonus/equity: compyny bo...
Good manufacturing practices (gmp)
Computerized system validation
Data integrity per 21 cfr part 11
The Quality engineer facilitates and enforces compliance with Good Manufacturing Practices (GMP) and corporate quality policies at the PR01 plant, focusing on utilities, equipment, computerized systems, and facilities in oral solid manufacturing

Job Summary

  • The Quality engineer facilitates and enforces compliance with Good Manufacturing Practices (GMP) and corporate quality policies at the PR01 plant, focusing on utilities, equipment, computerized systems, and facilities in oral solid manufacturing.
  • As part of the role will support project implementation for the site in all phases ensuring compliance with requirements and regulations.
  • Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Matching Summary

The Quality engineer facilitates and enforces compliance with Good Manufacturing Practices (GMP) and corporate quality policies at the PR01 plant, focusing on utilities, equipment, computerized systems, and facilities in oral solid manufacturing.

Salary

Base: $52,500 - $154,000; Bonus/Equity: Company bonus; Benefits: Comprehensive benefit program

Skills & Requirements

Must-have

  • Good Manufacturing Practices (GMP)
  • computerized system validation
  • data integrity per 21 CFR Part 11
  • oral solid manufacturing
  • utilities, equipment, facilities

Nice-to-have

  • strong leadership and organizational skills
  • sound judgment
  • teamwork oriented
  • strong customer service focus
  • bilingual (English/Spanish)

Key Requirements

  • Bachelor’s degree in Engineering
  • Minimum of 3 years of experience
  • FDA regulated environment
  • PE or EIT, preferred
  • Authorized to work in the United States

Work Rights

Authorized to work in the United States

Tailored Resume

Cover Letter