Representative - QA - IAPI (R2-R3)

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 72,000 - 101,000; Full time

Benefits offered by this job

Company bonus

Comprehensive benefits package

401(k) plan

Job summary

Eli Lilly and Company seeks a Representative - QA - IAPI (R2-R3) to provide quality support to Indianapolis API Operations manufacturing and laboratory areas and to ensure robust quality systems and GMP compliance.

Responsibilities include reviewing GMP documentation, contributing to deviation investigations, change control, and mentoring QA specialists while supporting 24-hour operations and potential telecommuting.

Qualifications

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or related scientific field.
• At least 2 years of experience with cGMPs and quality systems.
• Experience across QA, QC, Manufacturing, Engineering, Technical Services, or Regulatory Affairs (2 years).
• At least 1 year experience with statistical tools.
• Experience in Deviation Management, Change Management, and Inspection Readiness.
• Must support 24 hour/day operations.
• Part-time telecommuting may be permitted.

Responsibilities

• Provide quality support to Indianapolis API Operations manufacturing and laboratories.
• Review and approve key GMP documentation and contribute to investigations.
• Support deviation investigations, change control proposals, and quality guidance.
• Maintain quality systems, review analytical data, and prepare for inspections.
• Mentor QA Specialists and participate in customer complaint investigations.

Skills

QA / Quality Assurance

Quality Control

cGMPs

Statistical tools

Deviations handling

Change management

Inspection readiness

Regulatory affairs

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Pharmacology

Related scientific field

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Eli Lilly and Company seeks a Representative - QA - IAPI (R2-R3) to provide quality support to Indianapolis API Operations manufacturing and laboratory areas and to ensure robust quality systems and GMP compliance. Review and approve key GMP documentation, contribute to deviation investigations and change control proposals, and provide quality guidance across manufacturing, materials, utilities, maintenance, and laboratory operations. Maintain quality systems, perform analytical data review, support product and process assessments, and prepare for internal and external regulatory inspections. Participate in customer complaint investigations, stability and analytical data review, and the disposition of API intermediates and raw materials. Contribute to quality system improvement and provide mentoring to QA Specialists.

Position requires a Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or a related scientific field and 2 years of academic or employment experience with cGMPs and quality systems. Academic or employment experience must include: 2 years of experience with Quality Assurance, Quality Control, Manufacturing, Engineering, Technical Services, or Regulatory Affairs; 1 year of experience with statistical tools and analysis; and experience in Deviation Management, Change Management, and Inspection Readiness. Must support 24 hour/day operations. Part-time telecommuting may be permitted.

Rate of Pay: $71,531.00 - $101,275.00 per year.

Job location: Indianapolis, IN.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, 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).

• Africa, Middle East, Central Asia (AMECA)
• Black Employees at Lilly (BE@Lilly)
• Chinese Culture Network (CCN)
• EnAble
• Evolve
• Lilly Indian Network (LIN)
• Organization of Latinx at Lilly (OLA)
• Pride (LGBTQ+ Allies)
• Veterans Leadership Network (VLN)
• Women's Initiative for Leading at Lilly (WILL)

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!