GMP Materials QA Specialist

Eli Lilly and Company; Lebanon (IN); In loco; USD 66.000 - 172.000; Tempo pieno

Vantaggi offerti da questo lavoro

Company bonus

401(k) plan

Healthcare benefits

Vacation benefits

Well-being benefits

Descrizione del lavoro

Eli Lilly and Company is seeking a Materials Management/GMP Quality Assurance professional to join the Lilly Medicines Foundry project in Indiana. You will help ensure timely release of raw materials, maintain supplier qualifications, and support regulatory inspections.

The role requires a Bachelor’s degree in a related field, 3+ years in pharmaceutical QA, and US work authorization. You’ll work in a fast-paced, compliance-driven environment centered in Carmel/Lebanon, IN with opportunities to

Competenze

• 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; Lilly does not provide visa sponsorship.

Mansioni

• Serve as a materials management expert, mentoring MMQA, Foundry Materials Management and PR&D.
• Develop processes and strategies to ensure timely release of raw materials, excipients, GMP consumables and packaging components and supplier qualifications.
• Oversee qualification of all suppliers of purchased materials for use in GMP operations.
• Collaborate with site staff and global resources for risk assessments and 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.
• Perform SAP data steward functions.
• Review redline GMP documents including specifications and procedures.
• Track and report materials management metrics to supplier meetings and governance committees.
• Support regulatory inspections with documentation and SME support.
• Evaluate product quality impact for GMP incidents and support RCA/CAPA.

Conoscenze

Quality Assurance

US work authorization

Formazione

Bachelor’s degree in science/engineering/pharma

Strumenti

SAP

Descrizione del lavoro

Eli Lilly and Company is seeking a Materials Management/GMP Quality Assurance professional to join the Lilly Medicines Foundry project in Indiana. You will help ensure timely release of raw materials, maintain supplier qualifications, and support regulatory inspections.

The role requires a Bachelor’s degree in a related field, 3+ years in pharmaceutical QA, and US work authorization. You’ll work in a fast-paced, compliance-driven environment centered in Carmel/Lebanon, IN with opportunities to