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Quality Assurance
4 months ago
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 for QCL (Quality Control Laboratories) Representative provides daily oversight, assistance, and guidance to issues such as analytical investigations, deviations, change control proposals, procedure / master formula revisions, validations, commissioning, and qualification activities. The QA for QCL 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 yourself and others by supporting HSE corporate and site goalsLead, mentor, and coach QCL on quality mattersEnsure regular presence in laboratories to monitor GMP programs and quality systemsActive member of the lab areas they support through day-to-day presence and participation with project workApprove test plans and analytical investigationsAssess and triage deviations that occur as well as approve minor deviationsWork cross functionally with QCL, Equipment team, and Manufacturing to resolve issues while adhering to quality and documentation requirementsParticipate in self-led inspections and provide support during internal / external regulatory inspectionsAbility 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 in Lean Projects to help improve productivity within the local areaSupport project and process improvement initiatives for QCL as a representative of the Quality FunctionApprove commissioning qualification / validation documents for computer systems and equipment to ensure compliance with quality standardsNetwork with Global Parenteral Network sites as resources and benchmarking sources, as applicable flexibility within job assignmentParticipate in the investigation of analytical investigations or deviations, write / review change controls, and investigate deviations as required.Basic Qualifications:Bachelor's or equivalent (Science or Engineering related degree preferred).Demonstrated equivalent experience in a GMP facility.Additional Preferences:Demonstrate strong oral and written communication and interpersonal skillsDemonstrated risk based decision making and problem solving skillsDemonstrate knowledge and understanding of manufacturing processes and Quality SystemsDemonstrate technical writing and communication skills.Proven ability to work independently or as part of a team to resolve an issueStrong attention to detailExperience in GMP production environments or QCL is desirablePrevious experience with Lilly Event and Change Management processesProficiency with computer systems including Microsoft Office products, Veeva, TrackWise, Darwin, SmartLab and/or MODA.Other Information: 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. 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 ( ) 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
