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.

The QA Representative for manufacturing floor support within the Indianapolis Parenteral Manufacturing site provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities in support of making and releasing medicine to patients around the world. The QA Representative will be a member of a cross functional process team supporting manufacturing processes and will also advise and provide support for other floor support QA Representatives. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.

Responsibilities:

• Responsible for adhering to safety rules and maintaining a safe work environment for both you and others by supporting health, safety and environmental corporate and site goals

• Lead, mentor, and coach operations and support personnel on quality matters

• Ensure regular presence in operational areas to monitor GMP programs and quality systems

• Active on local process team, as outlined in MSOE (manufacturing standards of operational excellence) standards, or indirect participation through project support activities

• Ability to assess and triage deviations that occur within the local process team

• Work with Lilly support groups and external partners to resolve or provide advice on product related issues

• Participate in self-led inspections and provide support during internal / external regulatory inspections

• Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)

• Participate and contribute in/to Lean initiatives to help improve productivity within the local process team or quality organization

• Support project and process improvement initiatives for Plant Process Teams as a representative of the Quality function

• Approve commissioning, qualification and validation documents for computer systems and equipment to ensure compliance with quality standards

• Network with Global Parenteral Network sites as resources and benchmarking sources as applicable

Basic Requirements:

• Bachelor's or equivalent (Science or Engineering degree)

• Demonstrate knowledge and understanding of manufacturing process and Quality Systems

Additional Skills/Preferences:

• Experience in GMP production environments or Quality Assurance

• Previous experience with Deviation/Event, Root Cause Investigation and Change Management processes

• Proven ability to work independently and as part of a team to resolve issues

• Critical thinking and understanding of compliance expectations

• Demonstrate strong oral and written communication and interpersonal skills

• Demonstrate technical writing and communication skills

• Demonstrated decision making and problem-solving skills

• Strong attention to detail

• Proficiency with computer systems including Microsoft Office products, TrackWise, PMX, and SAP

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 Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

• May be subject to Post Offer Exam

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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