Associate-Quality Assurance-Data Integrity

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.

Facilitate and enforce compliance with Good Manufacturing Practices and corporate quality policies as applied to the areas of utilities, equipment, computerized systems and facilities in solid dosage manufacturing sites.  Review/execute "Audit Trails" in computerized systems (e.g. GMARS) ensuring compliance with global quality standards and local procedures ensuring compliance with Data Integrity expectations.  It will support equipment connectivity initiatives in the manufacturing area by approving/reviewing associated documentation, and registering equipment in the GMARS system, among other activities.

Responsibilities:
Ensure compliance with Good Manufacturing Practices (GMPs) and corporate quality policies with special attention to the following elements
Support or perform audit trail Review for GMARS system

Support equipment connectivity activities, as required

Support data integrity deviations assessments and change control evaluation as part of the business day to day, as needed.

Basic Requirements:

• Bachelor’s degree in science (chemistry) or engineering (chemical, mechanical or industrial)
• At least 2 years of experience in facilities, equipment, utilities in a highly regulated pharma environment
• PE/EIT, preferred

Additional Skills/Preferences:

• Bilingual (English and Spanish)
• Ability to establish positive interpersonal relationships and interact with people
• Ability to multi-task and work on multiple projects at once
• Strong compliance mindset and sound judgment
• Work under minimal supervision
• Knowledgeable in GMPs, GDPs, Computerized System

This position is for a fixed term up to a maximum of one year.

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.

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