Job Description
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.About Us: Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. We are seeking a highly motivated, talented Quality Assurance Associate to support our new Biologics Manufacturing Facility. The ideal candidate is an organized and methodical professional who fosters a positive team environment.Main Purpose and Objectives of Position:The QA Associate is responsible for building a state-of-the-art, digitally enabled QMS and ensuring that the Quality System(s)/Program remains in a validated state and within regulatory commitments. Supporting the definition and implementation of Digital Plant systems and capabilities in the Quality Assurance, System and Compliance function, defining digital plant business needs and user requirements, ensuring that the end user requirements are well understood and incorporated into the design, and that the applications and systems used are appropriately configured and integrated to fulfill the business need and enable a Digitally Native operation. Assures consistent implementation of standards across the quality system. Manages quality-related matters specific to quality systems & compliance. Performs design and ongoing monitoring of relevant QA programs.The QA Associate will combine their knowledge of Quality system compliance operations with analytical tools, data handling, modeling and visualization skills, science and engineering, to deliver digital plant solutions to the Limerick manufacturing operations. Part of the role will involve working with local and global IT experts and system owners to understand digital system capabilities and system positioning, as well as close collaboration with operations, engineering, TS, QA and QC to understand interdependencies between business processes and digital applications.Key Responsibilities:Co-ordinate the site program to ensure compliance with the Global Quality Standards. Drives efficiencies in this process.Reports and escalates critical quality issues in relation to monitoring of quality systems, verification of the effective implementation of key GMP programs and reviews of systems that impact safety, product quality to ensure that they operate in a state of control.Translate the business needs into user requirements for all new digital technologies & solutions in Quality Assurance that will deliver an automated, paperless, fully integrated, data analytics driven operations and business processes.Co-ordinate and report site compliance information and management review reports.Co-ordinate and support Change Management, Trending and activity planning business process owners.Interpret and apply emerging Global Quality System changes, Regulatory & GMP guidelines to the specific Quality System(s)/Program.Generate and report metrics such as observation metrics, backlog metrics, change control metrics to senior management and for incorporation into relevant site trending scorecards.Digital strategy development; in collaboration with the business process owners, own the business process maps for function and be responsible for the continuous improvement of the digital elements.Identify and assess new digital technologies and platforms that can enhance efficiency.Technology Integration; oversee the integration of digital tools and platforms across QA operations. Ensure seamless data flow and interoperability between existing and new systems.Develop the standard workflows for how we will use digital technology within our QA processes and operations.Support strategies for operational offline and online shakedown and testing of digital solutions post-implementation by IT. Work with the relevant functions to develop test scope and ensure it is planned and executed appropriately.Liaise with operations and IT to develop best training practices to ensure an efficient, effective, and timely knowledge transfer to the end users.Support the implementation of these digital solutions.Develop the user requirements for the site's Data Collection and Data Analytics needs.Lifecycle owner for the Quality Assurance function’s Digital roadmap. Stay abreast of industry trends and advancements in digital technologies to continuously improve the company’s digital capabilities.Support site GMP inspections ensuring appropriate technical resources are identified to support inspections.Additional skills/experience:Minimum of 5 years’ experience in GMP operations, IT management, or technology integration roles, preferably within the biotech or pharmaceutical industry.Personal considerations: The role operates on a standard working week. The job may also involve some non-scheduled call-in time to respond to emergencies etc. and some scheduled call-in time.Educational requirements: BSc (Level 8 Degree Minimum), MSc, or PhD in Biotechnology, Chem, Eng or related discipline with appropriate experience.Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly 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.#WeAreLilly #J-18808-Ljbffr