Principal Associate - QA

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.

Key Responsibilities:

• Ensure appropriate execution of the Quality Systems to sustain cGMP compliance.
• Ensure adequate document control and data integrity for packaging instructions and cGMP standards.
• Review/approve/release batch records.
• Create/verify Certificates of Analysis.
• Provide quality support for packaging operation.
• Investigate, review/approve deviation investigations.
• Review/approve change controls, protocols and master label proofs.
• Review/approve allowable dating, stability justifications and retest dating for CT Materials.
• Provide Quality oversight for Collaboration Partners as needed.
• Assist with regulatory body audits and site self-inspections to ensure cGMP compliance.
• Provide guidance to counterparts within organization.

Educational Requirements:

• Bachelor of Science degree, or relevant specialized experience and training needed to fulfil the responsibilities of this position.

Basic Requirements:

• Experience in pharma or CT packaging or manufacturing
• Strong knowledge of cGMPs, Quality Systems and FDA Regulations

Additional Preferences:

• SAP Power user experience
• Standard Operating Procedure writer experience.
• Ability to work across functional areas with people of all levels of the organization.
• Strong oral and written communication skills.
• Demonstrated interpersonal and networking skills.
• Ability to gather, edit, organize, and summarize information from multiple sources including databases, websites, site interviews and audits.
• Ability to influence team interactions and lead initiatives.
• Must exhibit attention to detail.
• Ability to work under time pressure with proven demonstration of good judgement in making decisions under minimal supervision.
• Excellent teamwork skills

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 ( [email protected] ) 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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