Materials Management QA Specialist

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 66 000 - 172 000; Plein temps

Avantages offerts par ce poste

Company bonus

401(k)

Pension

Vacation benefits

Medical benefits

Résumé du poste

Lilly is seeking a Quality Assurance professional to support the Lilly Medicine Foundry initiative in Indiana. You will supervise supplier quality, ensure GMP compliance, and collaborate with MMQA and R&D to ensure material integrity across raw materials and packaging components.

The role emphasizes risk assessment, batch disposition, regulatory readiness, and documentation control to enable high-quality medicines. Strong writing and cross-functional collaboration are essential.

Qualifications

• Education Level: Bachelor's degree in a science, engineering, computer-related, or pharmaceutical field, or equivalent industry experience.
• 3+ years working in the pharmaceutical industry in Quality Assurance roles.
• Authorized to work in the United States on a full-time basis.

Responsabilités

• Serve as a materials management expert, mentoring MMQA, Foundry Materials Management, and PR&D.
• Develop processes to ensure timely release of raw materials, excipients, GMP consumables and packaging components and supplier qualifications to support business needs.
• Oversight and support of qualification of all suppliers of purchased materials for use in GMP operations.
• Collaborate with site staff and global resources to assist/conduct risk assessments and provide recommendations for Supplier/Service Provider approval.
• Participate in periodic reviews of supplier performance.
• Write and coordinate Supplier, Service Provider, and Affiliate Quality Agreements.
• Represent the voice of quality to material management and supplier certification committees.
• Provide operational oversight for incoming receipt, sampling, and testing.
• Perform batch disposition of incoming materials/consumables.
• Review/redline GMP documents including specifications and procedures.
• Track and report materials management metrics to Supplier Relationship Meetings and committees.
• Support regulatory inspections with SME support.

Connaissances

Quality Assurance

GMP

SAP

Regulatory knowledge

Technical writing

Formation

Bachelor's degree in science/engineering/pharma

Outils

SAP

Description du poste

Lilly is seeking a Quality Assurance professional to support the Lilly Medicine Foundry initiative in Indiana. You will supervise supplier quality, ensure GMP compliance, and collaborate with MMQA and R&D to ensure material integrity across raw materials and packaging components.

The role emphasizes risk assessment, batch disposition, regulatory readiness, and documentation control to enable high-quality medicines. Strong writing and cross-functional collaboration are essential.