Associate - IDAP QA

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.

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.

Position Description:

The Quality Assurance (QA) Representative for IDAP 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. The QA Representative also advises and provides support for other floor support QA Representatives. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Inspections by various regulatory agencies.

Responsibilities:

• 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 standard, 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 / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
• Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.
• Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function.
• Approve commissioning, qualification / validation documents for computer systems and equipment to ensure compliance with quality standards.
• Network with other device and packaging sites as resources and benchmarking sources as applicable flexibility within job assignment.

Basic Requirements:

• Bachelors Degree (Science or Engineering related degree preferred) or demonstrated equivalent experience in a GMP facility
• Demonstrated strong oral and written communication and interpersonal skills.
• Demonstrated decision making and problem-solving skills.
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
• Demonstrated technical writing and communication skills.
• Responsible for adhering to safety rules and maintaining a safe work environment for both you and others by supporting HSE corporate and site goals.

Additional Preferences:

• Proven ability to work independently or as part of a team to resolve an issue.
• Strong attention to detail.
• Experience in GMP production environments or QCL is desirable.
• Previous experience with Lilly Event and Change Management processes.
• Proficiency with computer systems including Microsoft Office products, Veeva, 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 IDAP Plant. Some allergens are present in the IDAP Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• May be subject to Post Offer Exam.
• May be subject to a background check for handling of Lilly SSS/CS
• 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.

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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