Quality Assurance Associate - Manufacturing Compliance

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 global 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 representative provides support to manufacturing and ensures quality systems and GMP compliance.  The QA representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production batch record revisions, validations, and batch dispositions.  The QA representative’s position is essential for maintaining quality systems, ensuring GMP compliance and ensuring an inspection readiness state.

Responsibilities:

• Provide direct oversight, quality guidance, and recommendations in support of production

• Review and approve documents including, but not limited to, procedures, master production records, equipment qualifications, and process validations

• Assess and support deviation investigations, CAPA effectiveness, and change control proposals

• Participate in aberrant data investigations

• Perform batch record review and disposition activities

• Conduct gap assessments of global requirements and ensure implementation into local procedures

• Provide “on-the-floor” manufacturing support and participate in routine production walkthroughs and lead self -inspection activities related to systems, data integrity, and GMP compliance

• Participate in regulatory inspection activities and support regulatory inspections as it relates to the production and other quality systems

• Lead and/or support the assessment, development, and implementation of site projects in support of continual Quality Management System improvements

• Prepare quality metrics and share with process teams for the purpose of continuous improvement and reduction of operational variability (i.e. observation/deviation occurrence)

• Serve as the conduit of information flow between process team and quality representatives in other supporting areas

• Engage with site Quality Leadership to influence changes and continuous improvement with respect to the Quality management system supporting production and other areas

• Maintain current awareness of regulations, industry trends, and regulatory agency interpretation of GMP requirements 

• Assist with training and development needs of self and others and create opportunities for knowledge sharing (coordinating benchmarking sessions)

• Assist others in the interpretation of regulatory and corporate requirements. 

• Support and abide by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined

Basic Requirements:

• Bachelors degree or higher in the sciences, engineering, or related field with 1-3 years of experience. Would consider HS diploma with 3-5 years of relevant work experience.

• Strong knowledge of GxP and quality systems in GMP operations within the Biopharmaceutical industry related to Production, Laboratory, Medical/Regulatory/Safety, etc.

​Additional Preferences:

• Proficiency in planning and ability to carry out tasks individually and as part of a team, with minimal supervision

• Demonstrated ability to communicate including good oral, written and presentation communication skills

• Demonstrated ability to interpret and apply quality requirements to different situations by understanding customer needs and applying good problem-solving skills

• Demonstrated ability to effectively communicate quality concepts to a multiple range of personnel

• Ability to build relationships across dimensions of difference, ask questions & invite others to contribute

• Demonstrated Business Acumen

• Speak up with ideas, concerns & to ensure safety of others

• Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings

• Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues

• Demonstrate courage & integrity

• Demonstrated success in influencing without authority

• 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

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.

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). 

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