QA Engineer

• Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent
• Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness
• Translate global quality standards, cGMP, and regulatory requirements into site-level procedures
• Facilitate decision making within the team under tight deadlines
• Effectively communicating and managing internal and external stakeholders
• Proactively managing issues, proposing, and implementing plans to resolve as needed
• Provide quality oversight in Analytical testing, namely: molecule support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records)
• Ensure that appropriate quality systems are in place and are being utilized
• Facilitate quality improvement initiatives, and the implementation of new quality standards
• When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data
• Coach/mentor others regarding investigations are conducted for deviations, stability failures and out of specification (OOS) results
• Review and approval of the corresponding documentation
• Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices
• Promote a positive quality culture and oversee quality presence in the respective laboratory areas

Associate Director – Analytical Quality Assurance

Quality Engineer – Trainer

QA Engineer, Foundry

Quality Assurance Supervisor

QA Associate – Dry External Intermediates Manufacturing