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Lilly API EM Quality Assurance Representative in Indianapolis, Indiana

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.

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.

Organization Overview:

The API External Manufacturing Quality Assurance Representative provides support to all quality activities including batch disposition of API batches at Contract Manufacturing organizations (CMs). The QA Representative’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.

Responsibilities:

  • Serve as a liaison between CMs and Lilly.

  • Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.

  • Escalate quality issues at CMs to Lilly QA management.

  • Assist in the establishment and revisions of Quality Agreements with affiliates and customers.

  • Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).

  • Coordinate and perform QA responsibilities of API shipments.

  • Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.

  • Evaluate and disposition API batches.

  • Ensure that documented checks have been completed for the Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.

  • Provide quality support of API with the focus on holistic review of key activities associated with or impacting the manufacturing processes.

  • Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.

  • Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.

  • Participate in APR activities.

  • Holistically review control chart data and the impact of all deviation investigations and changes to ensure all processes are in an appropriate state of control.

  • Participate in Post Launch Optimization Teams (PLOT).

Basic Requirements:

  • BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.

Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.

Additional Skills/Preferences:

  • 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.

Additional Information:

• Travel 20%

• Indianapolis

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.

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. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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