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Lilly Flow Mentor- QA in Indianapolis, Indiana

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 35,000 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.

Description:

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 35,000 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Quality Assurance Flow Mentor provides technical leadership and expertise for production operations in the areas of: Coaching and Mentoring Front Line Process QA Reps, Developing and Sustaining Process Knowledge, Process & Equipment Support, Process Optimization & Continuous Improvement, Developing and Sustaining Quality Systems, and Adherence to Business Systems. The Flow Mentor participates in regulatory inspections, collaborates in the site inspection readiness program, and advises the lead investigators, functional leaders and Site Quality Leader in manufacturing issues.

Responsibilities:

Coach and Mentor Front-Line QA Reps

  • Lead Qualification efforts for new frontline QA reps.

  • Coach and mentor front-line process QA reps in aspects of fundamental QA support including process understanding (both theoretical and practical), problem solving, project management, and deviation resolution.

  • Related experiences with troubleshooting bio-purification and traditional unit operations such as chromatography, tangential flow filtration, fermentation, homogenization, evaporation, mixing, and distillation.

  • Champion the application of statistical thinking and use of data to monitor process performance and make risk based QA decisions.

  • Support and peer review root cause analysis around operational events.

  • Promote and peer review documentation of learning points, Gap assessments, and event investigations.

  • Provide technical support to non-routine (e.g., deviation) investigations.

  • Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives.

Provide Process & Equipment Support

  • Identify 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 front-line QA reps

  • Participate in the APR process

Process Optimization & Continuous Improvement

  • Review, identify and drive alignment of QA systems across IAPI.

  • 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.

Adherence to QA/Business Systems

  • Provide support to the QA organization for deviation reduction and backlog prevention initiatives.

  • Chair the Deviation Review Board / Change Review Board

  • Analyze process/unit team metrics for awareness and identification of potential improvement opportunities:

  • Deviation Cycle Time

  • Event Root Causes

  • Overdue CAPA items

Basic Requirements:

  • BSc or MSc in chemistry, biology, engineering, or equivalent scientific degree

  • 3 or more years in the Pharmaceutical Industry

Additional Preferences:

  • Experience in TS/MS, Engineering, QC, QA is preferred

  • Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements

  • Knowledge of protein chemistry & process/cleaning validation.

  • Experience leading root cause investigations

  • Excellent technical writing skills

  • Ability to function in a team environment as a leader and as a member of teams.

  • Ability to partner/network outside the IAPI site and participate in inspection readiness/continuous improvement initiatives.

Additional Information:

  • The normal schedule for this position is Monday-Friday, 8 hours/day. However, emergency situations may require additional support beyond this normal schedule.

  • Travel (domestic and international) may be required

  • No certifications required.

  • Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

#WeAreLilly

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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