Quality Control Associate (r1-r3)

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

Quality Control Associate at Eli Lilly responsible for technical support in pharmaceutical device testing, including design verifications, process validations, stability testing, and batch release testing. The role involves investigating quality deviations, supporting change management, reviewing GMP laboratory data, and participating in regulatory inspections. Requires a Bachelor's degree and experience in quality control operations for parenteral or pharmaceutical products, documentation systems, and regulatory requirements like CGMP and ISO13485.

What you'd actually do

  1. Provide quality control technical support for design verifications, process validations, stability testing, and batch release testing.
  2. Investigate quality observations and deviations using root cause analysis.
  3. Support change management processes through impact analyses.
  4. Review and approve Good Manufacturing Practices (GMP) laboratory data and documentation, including protocols, methods, technical reports, procedures, sampling plans, and rework, retest, and resample instructions.
  5. Perform comprehensive technical review of lot release testing data.

Skills

Required

  • Bachelor’s degree in Biotechnology, Biomedical Engineering, or a closely related field
  • 1 year of experience with quality control laboratory operations and device testing
  • 1 year of experience with quality control operations for parenteral products, dry products, or pharmaceutical devices
  • 1 year of experience with writing requirements documents and developing training materials
  • 1 year of experience with analytical lab equipment, including Zwick, CADI, and MicroVu
  • 1 year of experience with documentation management systems, including Veeva and Quality Docs
  • 1 year of experience with quality systems and regulatory requirements, including CGMP, 21 CFR 820, ISO13485, and EU Medical Device Directive

Nice to have

  • Up to 5% domestic and international travel

What the JD emphasized

  • CGMP
  • 21 CFR 820
  • ISO13485
  • EU Medical Device Directive