Sr. QA Associate for QC Labs - API
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.Job DescriptionOrganization 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.Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.The Lebanon API QA Representative for the Quality Control Laboratory provides daily oversight, assistance, and mentorship to laboratory issues such as non-conformance investigations, change control proposals, validations, Final COA disposition, commissioning, and qualification activities. Individuals in this role will advise and provide support for other QA for QC Representatives. This position is critical for maintaining GMP compliance and providing support during preparation for Pre-Approval and General Inspections by various regulatory agencies.Responsibilities:
Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals
Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up of the QC Laboratory
Lead, mentor , and coach laboratory and support personnel on quality matters
Ensure regular presence in laboratory areas to supervise GMP programs and quality systems
Active on local process team, as outlined in MSOE standard, or indirect assistance through project support activities
Ability to assess and triage deviations and 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
Contribute in self-led inspections and assist during internal and 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)
Assist in Lean Projects to help improve efficiency 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 API Network sites as resources and benchmarking sources as applicable
Basic Qualifications:
Bachelor's degree in related industry (preference for Science, Engineering, or Computer Science degrees)
5+ years working in manufacturing QA roles (preference for pharmaceutical or medical device)
Additional Preferences:
Previous QC Lab oversight experience.
Strong oral and written communication and social skills
Six Sigma Green Belt or Lean Training/Experience
Demonstrated decision making and problem solving skills
Demonstrate knowledge and understanding of manufacturing process and Quality Systems
Demonstrate technical writing and communication skills
CQA certification from the American Society for Quality (ASQ) or sponsorship from Lilly
Ability to work independently or within a team to resolve an issue
Strong attention to detail
Experience in GMP production environments or QCL is preferred
Previous experience with Lilly Event and Organizational Change processes
Proficiency with computer systems including Microsoft Office products, Regulus, TrackWise, LIMS, Veeva and SAP
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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