Quality Assurance Operational Support

Scorpion Therapeutics; Lebanon (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Lilly in Lebanon, Indiana, is seeking a Quality Assurance Operational Support Representative for its advanced therapies manufacturing site. The role focuses on GMP compliance, supporting facility startup, and maintaining quality systems for clinical and commercial supply.

You will review documents, oversee equipment verification, investigate deviations, support regulatory inspections, and drive process improvements with cross-functional teams.

Qualifications

• Bachelor's in science, engineering, or related field.
• 3+ years pharmaceutical QA experience.
• Familiar with GMP and regulatory standards (US/EU/Japan) and equipment validation.

Responsibilities

• Provide technical and quality review of documents.
• Oversee equipment verification.
• Lead investigations of deviations, change controls, and batch record reviews.
• Support regulatory inspections.
• Lead/support process initiatives.
• Promote a strong quality culture.
• Monitor GMP adherence on-site.

Skills

Quality assurance

GMP compliance

Regulatory standards

Equipment validation

Education

Bachelor's degree

Tools

Veeva Vault

SAP

Automation platforms

Job description

Role

Quality Assurance Operational Support Representative for Lilly’s new advanced therapies manufacturing site, focusing on gene therapy modalities in Lebanon, Indiana. Objectives include ensuring GMP compliance, supporting facility startup, and maintaining quality systems for clinical and commercial supply.

Responsibilities

• provide technical and quality review of documents
• oversee equipment verification
• lead investigations of deviations, change controls, and batch record reviews
• support regulatory inspections
• lead/support process initiatives
• promote a strong quality culture
• monitor GMP adherence on-site

Requirements

• Bachelor’s in science, engineering, or related field
• 3+ years in pharmaceutical QA roles
• experience with GMP, regulatory standards (US, EU, Japan), and equipment validation

Preferred

• knowledge of gene therapy manufacturing processes
• technical writing skills
• proficiency with systems like Veeva Vault, SAP, and automation platforms

HighValue:

• gene therapy modalities
• manufacturing startup
• GMP compliance
• equipment validation
• regulatory inspection support
• cross-functional team collaboration

WorkSetup:

not specified; likely on-site in Lebanon, Indiana.