Representative - QA - IAPI (R2-R3)

Regulatory Jobs; Indianapolis (IN); On-site; USD 72,000 - 101,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Time off & leaves

Well-being programs

Job summary

Lilly in Indianapolis, IN seeks a Representative - QA - IAPI to provide quality support to API operations manufacturing and laboratory areas and to ensure robust quality systems and GMP compliance.

The position requires a Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or related field and 2 years of experience with cGMPs and quality systems. Must support 24 hour/day operations. #LI-DNI

Qualifications

• Bachelor's degree or higher in a scientific field related to chemical engineering, biomedical engineering, pharmacology or similar.
• 2 years of academic or employment experience with cGMPs and quality systems.
• 2 years of experience with Quality Assurance, Quality Control, Manufacturing, Engineering, Technical Services, or Regulatory Affairs; 1 year with statistical tools and analysis.
• Experience in Deviation Management, Change Management, and Inspection Readiness.

Responsibilities

• Review and approve GMP documentation.
• Contribute to deviation investigations and change control proposals.
• Provide quality guidance across manufacturing, materials, utilities, maintenance, and laboratory operations.
• Maintain quality systems and perform analytical data review.
• Prepare for internal and external regulatory inspections.
• Mentor QA Specialists.

Skills

Quality Assurance

Quality Control

Regulatory Affairs

Engineering

Statistical Tools

Change Management

Deviation Management

Inspection Readiness

Manufacturing

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Pharmacology

Tools

GMP documentation

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. #LI-DNI

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. #LI-DNI

Job location: Indianapolis, IN.

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

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: 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) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $71,531.00 - $101,275.00 per year.

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

• 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).