Principal QA Rep - AQR

| Indianapolis, IN
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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.

The QA Batch Disposition Consultant (Authorized Quality Representative) is responsible for final disposition of Semi-Finished and/or Finished drug products. The QA Batch Disposition Consultant provides guidance to the site for Batch related issues, such as non-conformance investigations, issue resolution, and other batch disposition activities. Additionally, AQRs serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there are adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards.
  • Performs final batch disposition of 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 in a timely manner.
  • Lead, Mentor and Coach Site personnel on quality matters associated with the Batch / Batch Disposition process.
  • 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 Six Sigma project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.

Basic Requirements:
  • Bachelors or equivalent (Science or Engineering related degree preferred).
  • Minimum 5 years experience in pharmaceuticals or a regulated manufacturing environment.

Additional Skills/Preferences:
  • Proven ability to work independently or as part of a Team to resolve an issue
  • Previous experience with Lilly 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
  • Demonstrated relevant experience in a GMP facility.
  • Ability to make technical decisions, provide guidance to the site and lead others
  • Proficiency with applicable computer systems
  • Demonstrated strong oral and written communication skills.
  • Demonstrated interpersonal skills and the ability to work 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.

Additional Information:
  • Work off-shift 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 ( [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.

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 [email protected]
More Information on Eli Lilly and Company
Eli Lilly and Company operates in the Biotech industry. The company is located in Indianapolis, IN and Indianapolis, IN. Eli Lilly and Company was founded in 1876. It has 39451 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 107 open jobs at Eli Lilly and Company, click here.
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