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.Responsibilities :The QA Representative for the Floor Support team member 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. 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.Key Objectives/Deliverables:
Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE 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 standard, or indirect participation through project support activities
Ability to assess and triage deviations / observations 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 Global Parenteral Network sites as resources and benchmarking sources as applicable flexibility within job assignment
Basic Qualifications/Requirements:
Bachelors or equivalent (Science or Engineering related degree preferred).
Demonstrated equivalent experience in a GMP facility
Additional Skills/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, Regulus, TrackWise, PMX, and SAP
Demonstrate strong oral and written communication and interpersonal skills
Demonstrated decision making and problem solving skills
Demonstrate knowledge and understanding of manufacturing process and Quality Systems
Demonstrate technical writing and communication skills
Additional Information :
This is a 12 hour night shift role on a 3-2-2-3 rotating schedule
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
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.#WeAreLilly