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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$51,000 - $115,500

Organization Overview:
Quality Assurance Organization unit is responsible for the compliance oversight of the manufacturing operations. This position is an Associate - Quality Assurance to support MES activities (Electronic Batch Records).

Responsibilities:

This role will be working specifically with activities related to electronic batch records.Active participation on team meetings to provide input on project timeline considerations, activities, escalations and status of assigned tasks.Evaluate paper batch record and instructions to align it with electronic batch record requirements. Review operational processes and how they translate into electronic batch records. Serve and support the recipe authors for batch record construction and suggest path forward. Revise and approve configuration documents.Participate in the revision of the flow charts of the electronic batch record objects related to the manufacturing stages and steps.Review of all PMX objects related to an electronic ticket. Participate on objects verification on system, including issuance of summary of changes to ease the revision process. Review documentation associated to PMX production procedures (Core documents and their Attachments – Visio, Master Data, EQM, Choice list, History of changes.Evaluation of Stabilization forms that may arise after transitioning from paper batch records to electronic batch records. Approve SOPs related to electronic batch record changes or new implementations. Familiarize with PMX Objects update tracker to be used for transitioning activities. Perform Informal testing and formal testing stages. Execute Test Scripts and Test Scripts Data Sheet. Execute Formal Testing in the Application Lifecycle Management (or similar platform) and assist in resolution of defects generation if any. Revise test summary reports.Participate on objects transitioning activities and transition objects as needed. Ensure compliance with Data Integrity aspects.

Basic Requirements:

Bachelor’s degree or higher in science, engineering, or related fields5+ years of experience in GMP operations; at least 3 years on QualityUnderstanding and working knowledge of domestic and international data integrity regulations and other policies/regulations as applicable.Understanding of IT system design, controls, and usage.Knowledge and experience working with electronic batch record systems (e.g., Syncade, PMX)

Additional Skills/Preferences:

Bilingual (English/Spanish)Strong customer service skills and teamwork orientedSound judgmentAbility to communicate effectively with all levels and functions in the organization.Ability to work on multiple concurrent project initiativesAvailability to work irregular hours, on weekends and after regular working hours if requiredAbility to take initiative, to be assertive, to lead by example and to build high-quality relationships.Highly flexible, adapting to changes in priorities, requirements and processes is required

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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