Associate QA Representative - Peptide Manufacturing

Role Summary

The Quality Assurance representative provides support to LP1 API Operations manufacturing and ensures quality systems and GMP compliance. The role offers guidance in deviation investigations, change control proposals, procedure and master production recipe revisions, validations and batch dispositions. The position is essential for maintaining quality systems, ensuring GMP compliance, and preparing for inspections by regulatory agencies. This role supports the startup of Lilly's LP1 API manufacturing at the Lebanon, IN site.

Responsibilities

• Provide direct quality oversight to LP1 manufacturing and assist others in interpretation of regulatory and corporate requirements.
• Provide quality guidance, technical support and recommendations to equipment and process issues and continuous improvement initiatives.
• Work with cross functional teams to implement QA objectives.
• Prepare for and participate in internal and external regulatory inspections.

Qualifications

• Required: Bachelors Degree in Engineering or science related field.
• Required: 1+ years manufacturing experience.
• Required: Authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Preferred: Previous experience in pharmaceutical industry.
• Preferred: Previous experience in QA, TS/MS QC or Engineering.
• Preferred: Prior work with cGMPs or external regulations.
• Preferred: Demonstrated strong oral and written communication and interpersonal skills.
• Preferred: Demonstrated decision making and problem solving skills.