Quality Assurance Complaints Representative

2 weeks ago

Indianapolis, Indiana, 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.

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.

Responsibilities:

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.Basic Qualifications:Bachelors Degree required (Science or Engineering related degree preferred).1 or more years' experience in pharmaceutical facility preferred.Additional Skills/Preferences:Demonstrated relevant experience in a GMP facility.Proficiency with applicable computer systemsDemonstrated strong oral and written communication skills.Demonstrated interpersonal skills and the ability to work as a teamRoot cause analysis / troubleshooting skills.Demonstrated attention to detail and ability to maintain quality systemsResponsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.Ability to work independently or as part of a Team to resolve an issuePrevious experience with Lilly Complaint Management process.Proficiency with SAP, MES (PMX), and Darwin.Experience with Quality Management Systems (TrackWise or Veeva)Previous experience in QC, QA, Operations, TS/MS, Engineering or Regulatory is desirable.Technical Writing and Communication SkillsDemonstrated ability to work independently with minimal supervisionAdditional Information: 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 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 ( ) 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. #WeAreLilly

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