Senior Principal Associate QA (AQR) at Eli Lilly and Company (Indianapolis, IN)

| 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.

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.

The QA Batch Disposition Authorized Quality Representative (AQR) is responsible for final disposition of semi-finished and/or finished drug products. The QA AQR provides guidance to the site for batch related issues, such as non-conformance investigations, issue resolution and other batch disposition activities. Additionally, the AQR serves 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 cGMP standards.

  • Performs final batch disposition of semi-finished and/or finished drug product batches for Indianapolis Parenteral Manufacturing, including commercial and clinical trial materials to ensure high quality medicine is released to the market (cGMP compliance)
  • Leads, mentors and coaches site personnel on quality matters associated with batches and the batch disposition process
  • Provides guidance in operational area to ensure robust quality systems and GMP compliance
  • Participates in self-led inspection and/or provides support during internal / external regulatory inspections
  • Effectively reviews/approves GMP documents to ensure quality attributes are met
  • Participates in process improvement initiatives to improve productivity within the batch disposition work center and/or the site

Basic Requirements:
  • Bachelors degree or equivalent (science or engineering related degree preferred)
  • Minimum 5 years experience in a GMP regulated environment/facility

Additional Skills:
  • Proven ability to work independently or as part of a team to resolve issues
  • Ability to make technical decisions, provide guidance to site and lead others
  • Proficiency with applicable computer systems (e.g. SAP, MES (PMX), Darwin, Microsoft suite)
  • Demonstrated strong oral and written communication skills
  • Demonstrated interpersonal skills and ability to effectively work cross-functionally
  • Root cause analysis/troubleshooting skills
  • Demonstrated attention to detail and ability to maintain quality systems
  • Demonstrated relevant experience in GMP facility (parenteral manufacturing)
  • Maintain safe work environment by working safely and supporting HSE goals

Additional Information:
  • Work on off hours may be required
  • May work in various areas within the Parenteral Plant. Some allergens are present in the plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
  • Position is location onsite 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 (subject to applicable law).
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 108 open jobs at Eli Lilly and Company, click here.
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