Job Information
J&J Family of Companies Analyst Quality Systems in Latina, Italy
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Quality
Job Sub Function:
Quality Systems
Job Category:
Professional
All Job Posting Locations:
Latina, Italy
Job Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/
J&J Innovative Medicine is recruiting for a Analyst Quality Systems.
Principle responsibilities:
This role is part of the eLIMS Center of Excellence (CoE) Small Molecules (SM) and serves as a subject matter expert in the configuration and maintenance of master data within the eLIMS system. This role supports key processes such as the release of pharmaceutical, raw, and packaging materials, as well as Certificate of Analysis (CoA) generation in translating specifications into the eLIMS system using current business processes.
The incumbent independently creates, maintains, and reviews high-quality master data, conducts system testing and supports the creation and updating of system-related documentation. Additionally, the role identifies opportunities for process improvements and drives their implementation.
This role is responsible for managing and executing incoming requests promptly and effectively. To ensure the accuracy and integrity of master data, it is essential to have a comprehensive understanding of the site’s master data requirements and laboratory processes.
Additionally, the position involves the creation of training materials to foster knowledge sharing within the team, and actively participates in the development of team members through training and continuous personal growth.
The individual in this role is expected to support various projects within QC Operations, which could include the implementation of iLAB (paperless lab execution program) initiatives, process harmonization and standardization, master data support for consumer products and contract manufacturing organizations (CMOs). Furthermore, this position offers critical support to the Supervisor in managing COMET nonconformance investigations and proactively assessing change controls.
This position requires a high level of expertise and the ability to drive process improvement while ensuring compliance and operational excellence.
Qualifications
A minimum bachelor's degree or equivalent education/experience is required. A minimum of 2 – 4 years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS and Quality system is required. Extensive other experience with analytical testing, quality control or IT is preferred.
Ability to manage multiple issues, organize activities, prioritize, and escalate to management when appropriate. Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management.
Demonstrated strong written and verbal communication skills (Basic in English – B2) and the ability to develop and provide training to colleagues and partners.
Demonstrates flexibility in adapting to urgent needs. Ability to interact with local lab leaders on master data related issues as needed and maintain a strong relationship with local laboratories. Maintain a clear line of communication with the eLIMS CoE supervisor. High level commitment to meeting customer expectations as per strategic business needs.
“A pre-identified candidate for consideration has been identified. However, all applications will be considered”