Lilly Global Computer Systems Quality Assurance Representative in Humacao, Puerto Rico
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 35,000 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.
The Computer Systems Quality Assurance role is responsible for ensuring the Functional Area(s), Project(s) or System(s) to which they are assigned are in compliance with corporate Computer System Validation (CSV) standards. This includes providing consulting and interpretation of Corporate Computer Systems Standards and Practices (LQS/LQPs), providing oversight for CSV execution (including approving CSV documents per corporate standards/practices), maintaining awareness of corporate and external standards as they relate to CSV, and assurance of inspection readiness within supported areas.
This role will support a project for the implementation of a new (NextGen) Manufacturing Execution System (MES), as well as other day-to-day operations for Manufacturing & Quality IDS (MQ IDS) as needed.
Maintain Inspectional Readiness
Ensure supported systems are validated in compliance with LQS/LQPs
Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans
Participate in self inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
Ensure all Inspection Readiness materials (e.g. Tier 1-4) are current and appropriate
Provide periodic updates to key stakeholders
Escalate issues appropriately
Deliver Projects, Programs, and Support
Provide consulting and interpretation on LQS/LQPs as related to the supported computer system
Provide training to customer areas on CSV-related topics as needed
Partner with Business, Business Quality, and IT customer areas to deliver business value
Understand customer, company, and Quality priorities
Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
Engage customers and QA management in appropriate discussions of risk management
Ensure suppliers of computer systems or services meet quality expectations
Escalate computer system quality issues to the appropriate persons
Strive for and promote consistency within the CSQA Organization
Streamline and Continuously Improve
Eliminate non-value added activities in order to focus on activities which continuously improve assurance of quality. This may include engagement in Six Sigma projects and other process improvement activities.
Identify opportunity for streamlining and simplification and assist in developing improved solutions
Understand external trends and potential ramifications for the supported IT area(s)
Grow Capabilities and Knowledge
Share lessons learned and best practices with others
Act as an engaged team member
- Bachelor (4 yr College) degree in a technology-related field such as Computer Science; or equivalent experience (i.e., 3+ years experience in Automation/IT or computer system validation)
Understanding of process development and/or improvement (e.g. Six Sigma)
Experience leading and/or participation in delivering digital transformation programs in manufacturing, with LCM, new capabilities, and OCM components.
Manufacturing and/or Manufacturing Execution Systems experience.
Knowledge of multiple Lilly business areas
Broad IT technical competency
Ability to relate system use to potential impact to products and patients
Knowledge of IT Best Practices (e.g., LSEF, ITIL)
Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))
Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate
Proficiency with IT systems development life cycle
Proficiency with Lilly Computer Systems Validation and demonstrated ability to right-size validation based upon risk
Ability to focus across multiple processes (end-to-end viewpoint)
- QA Representative must complete CSQA Qualification Program
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).