Quality Control Associate (R1-R3)

Lilly • Indianapolis, IN

2d

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Eli Lilly and Company seeks a Quality Control Associate (R1-R3) to provide technical support for pharmaceutical device testing. Provide quality control technical support for design verifications, process validations, stability testing, and batch release testing. Investigate quality observations and deviations using root cause analysis. Support change management processes through impact analyses. 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. Perform comprehensive technical review of lot release testing data. Participate in regulatory agency and internal inspections. #LI-DNI

Requirements

• Position requires a Bachelor’s degree in Biotechnology, Biomedical Engineering, or a closely related field and 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
• Up to 5% domestic and international travel required.

Responsibilities

• Provide technical support for pharmaceutical device testing.
• Provide quality control technical support for design verifications, process validations, stability testing, and batch release testing.
• Investigate quality observations and deviations using root cause analysis.
• Support change management processes through impact analyses.
• 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.
• Perform comprehensive technical review of lot release testing data.
• Participate in regulatory agency and internal inspections.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees