Representative-IDAP QA Engineer

4 weeks ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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.

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 primary responsibilities of the QA Engineer are to assure compliance with corporate quality systems and current GMPs for the Operations of IDAP. This position provides quality oversight of the Production Quality System in support of operations, including assistance and mentorship in the execution of change controls, equipment qualification, process validation, computer system quality, deviations, and complaint investigations. This assignment will involve a high level of engagement with Operations, Engineering, and area Leadership.

Promote safety awarenessRemain current with individual training planObserve, promote, and follow requirements related to safety, quality, security, customer service, and GMPsProvide consultation and interpretation of quality guidance documents regarding qualification / validation, cleaning, change control, production practices, deviations, CSQ, and complaint managementProvide quality oversight and provide quality support for bringing new products into IDAPProvide quality oversight of the IDAP operations and processes to support QA Floor Reps / QA Specialists floor decisionsRaise notification to management for departures of critical nature and assure issues are addressedAssess gaps between local and corporate standards and facilitate remediation efforts actively working with support areasEnsure area is always audit readySupport project timelines assuring compliance with Quality expectationsProactively work with areas to provide support and promote consistency with Quality expectations and discuss resolution with process team membersPossess a detailed understanding of the IDAP processes including critical parameters, components used, equipment, etc.Actively assist in continuous improvements and efficiency projectsProvide quality impact assessments, reviews and approvals on validation protocols, qualification documents, change controls, deviations, holds, procedures, and maintenance work orders related to the IDAP processesActively seek expanded knowledge of applicable technologies, processes, and regulations through training, networking, floor presence, and project participationProvide leadership in communicating cGMP requirements to shop floor and promote best practices through direct contact with production, maintenance, engineering, and automationBasic Qualifications:Bachelor's Degree in STEM field required3 years experience in a GMP environment requiredAdditional Skills/Preferences:Previous experience in Quality Assurance or Engineering preferredKnowledge of cGMPs, Production Processes, Quality Systems, and FDA regulationsExperience supporting computer systems (e.g. CSV, CSQ, IDS experience)Proficiency with computer systems such as TrackWise, SAP, PMX, and Quality DocsExperience in conducting root cause investigations, and execution of change management, equipment qualification, and process validationAbility to communicate effectively with customers to carry out requirementsAbility to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solveAbility to influence team interactions and lead initiativesDemonstrated strong oral and written communication and interpersonal skillsDemonstrated decision making and problem solving skillsDemonstrated knowledge and understanding of manufacturing process and Quality SystemsDemonstrated attention to detailDemonstrated ability to coordinate and prioritize multiple tasks.Additional Information:Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needsOvertime and weekend work may be required.Individual must be available via cell phoneApplicant 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.Some travel may be required 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

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