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QA Principal Associate

4 months ago

Lebanon, United States Eli Lilly and Company Full time

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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN.  This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and systems to enable a successful startup into GMP manufacturing operations.

The API (Active Pharmaceutical Ingredient) Small Molecule Manufacturing Quality Assurance representative provides support to all quality activities at the Lebanon, Indiana facility. The QA representative position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated processes and are compliant to cGMPs and regulatory commitments.

Responsibilities:

Key Objectives/Deliverables:

Provide quality oversight of small molecule manufacturing operations with a focus on holistic review of key activities associated with or impacting the manufacturing processes.Serve as the initial point of contact for all quality-related issues.Coordinate and perform QA responsibilities of API manufacturing (small molecules).Review and approve documents including, but not limited to, procedures, master production records, change controls, deviations, equipment qualifications, analytical methods, process validations, and computerized system validations.Provide technical support for deviation investigations including root cause analysis, countermeasure development, and implementation of actions.Assess the impact of change controls and events on the product and regulatory commitments.Ensure all processes are in an appropriate state of control.Escalate quality issues to LP1 QA management.Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.Provide and coordinate designated sections for Annual Reports and Annual Product Reviews.Establish and monitor KPIs such as Right First Time (RFT), investigation timeliness and batch release.Work with Lilly support groups to resolve product related issues.Identify opportunities for and participate in continuous improvement.Participate in regulatory inspection preparations with small molecule manufacturing operations.Participate on the Technical Review Board.Ensure inspection readiness through compliance auditing, site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems.Complete other duties as assigned.


Basic Requirements:

Bachelor’s Degree (preference for Engineering, Chemistry, Biology, or science-related degree)5+ or more years in a pharmaceutical manufacturing environment


Additional Skills/Preferences:

Knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering, preferred.Experience in quality support for small molecule Drug Substance manufacturing.Thorough technical understanding of quality systems and regulatory requirements.Knowledge of pharmaceutical manufacturing operations.Demonstrated coaching and mentoring skills.Experience in root cause analysis.Demonstrated application of statistical skills.Demonstrated strong written and verbal communications skills.Strong attention to detail.Proficiency with computer system applications.Excellent interpersonal skills and networking skills.Ability to organize and prioritize multiple tasks.Ability to influence diverse groups and manage relationships.

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.

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