Representative - QA (Batch Disposition)

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 globe 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.

Responsibilities:

The Quality Assurance Batch Disposition Representative assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Device Assembly and Packaging activities.

The QA Batch Disposition Representative is responsible for disposition of Incoming Materials, Semi-Finished and/or Finished drug products. The QA Batch Disposition Representative provides guidance to process team members for Batch related issues, such as non-conformance investigations, issue resolution, and other batch disposition activities.

• Performs batch disposition of incoming materials, semi-finished and/or finished drug product batches for Indianapolis Device Assembly and Packaging, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
• Lead, Mentor and Coach Operation and support personnel on quality matters associated with the Batch / Batch Disposition.
• Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance.
• Participate in self-led inspections and/or provide support during internal / external regulatory inspections.
• Effectively review / approve GMP documents to ensure quality attributes are met (i.e. Non-conformances, procedures, protocols, specifications, and change controls).
• Participates in project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.

Basic Qualifications:

• Bachelors Degree OR 4 years of pharma experience (STEM related degree preferred).

Additional Preferences:

• Demonstrated relevant experience in a GMP facility.
• Proficiency with applicable computer systems.
• Root cause analysis / troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Proven ability to work independently or as part of a team to resolve an issue.
• Previous experience with Event and Change Management process.
• Proficiency with SAP, MES (PMX), and Darwin.
• Previous experience in QC or QA is desirable.
• Technical Writing and Communication Skills.

Additional Information:

• Overtime may be required.
• May be required to respond to operational issues outside of core business hours / days.
• Applicant may work in various areas within the IDAP Plant. Some allergens are present in the IDAP Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Position is located at the Lilly Technology Center - South.

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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