QA Primary Loop

Role Summary

QA Primary Loop position at Lilly focused on providing daily oversight, guidance, and support within Parenteral Visual Inspection to maintain GMP compliance and support pre-inspection readiness.

Responsibilities

• Lead, mentor, and coach Operations and support personnel on quality matters.
• Ensure regular presence in visual inspection areas to monitor GMP programs and quality systems.
• Collaborate cross-functionally as a core member of a manufacturing process team.
• Assess and triage deviations within the local process team.
• Coordinate with Lilly support groups and external partners to resolve product-related issues.
• Participate in self-led inspections and provide support during internal and external regulatory inspections.
• Review or redline documents to ensure quality attributes are met (deviations, procedures, technical studies, validation protocols, change controls, and engineering documents).
• Support project and process improvement initiatives for plant process teams.

Qualifications

• Bachelor's degree or equivalent (Science or Engineering related degree preferred).
• Strong oral and written communication and interpersonal skills.
• Demonstrated decision making and problem-solving skills.
• Technical writing skills.
• Preferred: Previous experience in GMP production environments or Quality Control Laboratories.
• Preferred: Knowledge of manufacturing processes and Quality Systems.
• Preferred: Ability to work independently or as part of a team to resolve issues and strong attention to detail.

Skills

• Quality assurance and GMP compliance
• Documentation review and redlining
• Cross-functional collaboration
• Deviations assessment and triage
• Process improvement and project support

Education

• Bachelor's degree or equivalent in Science or Engineering (preferred).

Additional Requirements

• Travel: Less than 10%
• Shift: Day shift, Monday‚ÄìFriday; may require responding to issues outside core hours
• Location: LTC-South; may work in various areas within the Parenteral Plant; exposure to allergens considered in applying
• Post-offer exam may be required