Scientist - IDAP Packaging QA Flow Mentor

Organization Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

The Scientist - IDAP quality assurance flow mentor provides technical leadership and expertise for quality production support in the following areas: coaching and mentoring QA floor reps, developing and sustaining process knowledge, process and equipment support, process optimization and continuous improvement, sustaining quality management systems, and adherence to business processes. The Scientist - IDAP quality assurance flow mentor participates in regulatory inspections, collaborates in the site inspection readiness program, supports the APR process, and advises lead investigators, functional leaders, and site quality leader on production issues.

• Coach and mentor QA floor reps through onboarding and qualification.
• Coach and mentor QA floor reps in process understanding, problem solving, project management, and deviation resolution.
• Support and peer review root cause analysis around operational events.
• Promote and peer review documentation of learning points, gap assessments, and deviations.
• Provide technical support to non-routine investigations and lead investigations for the quality function.
• Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives.
• Provide process and equipment support through identification of systemic issues affecting production (deviations, cycle time delays, etc.).
• Lead or participate in root cause analysis and countermeasure development and implementation for major compliance or throughput event investigations.
• Perform reviews of event documentation for technical accuracy and compliance.
• Provide back up and shutdown support for QA floor reps as needed.
• Identify and drive alignment of QA systems across IDAP.
• Support APR program.
• Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation.
• Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives.
• Collaborate with key support groups around the development of process knowledge and a common process improvement agenda.
• Provide independent peer input / review of technical activities.
• Provide support to the QA organization for deviation reduction and backlog prevention initiatives.
• Analyze process team metrics for awareness and identification of potential improvement opportunities.

• Bachelor's Degree or equivalent work experience
• 3 or more years in the pharmaceutical industry
• Qualified applicants must be 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.

• Demonstrated strong oral and written communication and interpersonal skills.
• Demonstrated decision making and problem-solving skills.
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
• Demonstrated attention to detail.
• Demonstrated ability to organize and prioritize multiple tasks.
• Experience in Quality, TS/MS, or engineering is preferred.
• Experience in device assembly and packaging processes.
• Good knowledge of cGMP, external regulations and Lilly quality systems and requirements.
• Experience leading root cause investigations.
• Excellent technical writing skills.
• Ability to function in a team environment as a…