Associate-Quality Assurance

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.

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.

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 Report.
• 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 fields
• 5+ years of experience in GMP operations
• Understanding 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 oriented
• Sound judgment
• Ability to communicate effectively with all levels and functions in the organization.
• Ability to work on multiple concurrent project initiatives
• Availability to work irregular hours, on weekends and after regular working hours if required
• Ability 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.

Additional Information:
This is a contract-based position.

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 ( Lilly_Recruiting_Compliance@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.

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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.

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