Quality Assurance Complaints Representative

Quality Assurance Complaints Representative

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 worldwide 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.

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

The Quality Assurance Complaints Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.

The QA Complaints Representative is responsible for coordinating and investigating complaints received by both internal and external customers associated with Incoming Materials, Semi‑Finished and / or Finished drug products. The QA Complaints Representative provides information related to complaints to process team members for non‑conformance investigations, issue resolution, and other process improvement activities.

• Coordinates and performs complaints investigations received from internal / external customers associated with incoming materials, semi‑finished and/or finished drug product batches for Indianapolis Parenteral products, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market and complaints investigated thoroughly.
• Lead, Mentor and Coach Operation and support personnel on quality matters associated with the Complaints.
• Provide support during internal / external regulatory inspections.
• Participates in Lean project or process improvement initiatives to improve productivity within the Complaints work center and / or the site.
• Perform and / or lead detailed complaint investigations.
• Perform initial visual / physical examination of returned complaint samples.
• Monitor incoming product complaints for trends and incidents that may relate to a quality issue with product.
• Support Annual Product Review process, including complaint and Reference and Retention Sample evaluation.
• Support and or lead other investigation types including Trends, Inter‑Company Complaints, and Deviation.

• Bachelors or equivalent (Science or Engineering related degree preferred).
• Demonstrated relevant experience in a GMP facility.

• Demonstrated relevant experience in a GMP facility.
• Proficiency with applicable computer systems.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to as a team.
• 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 Lilly Complaint Management process.
• Proficiency with SAP, MES (PMX), and Darwin.
• Previous experience in QC, QA, Operations, TS/MS, Engineering or Regulatory is desirable.
• Technical Writing and Communication Skills.

• Overtime may be required.
• Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Position is located at the Lilly Technology Center - South.

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