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

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

We are searching for the best talent for Analyst eLIMS CoE – QC Operations. Position can be based in any of our Operating Companies in Europe, preferably in Schaffhausen (Switzerland).

You will be responsible for:

This position works within the eLIMS CoE and is an expert in data setups in the eLIMS system to support lab processes including paperless, product release and CofA generations, especially to New Product Implementation for Large Molecules and Vaccines. This position independently creates, maintains and reviews high quality data setups, integrates instruments and applications and translates specifications within the eLIMS system using current business processes. This position reviews and tests system updates, creates and manages any system related documents, and identifies and drives process improvements.

This position takes ownership by completing any incoming requests in a timely manner. In order to maintain high quality data. This position is expected to fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete.

This position can develop training materials to enable sharing of knowledge within the team. This position trains others in immediate team while continuously improving personal training and knowledge. This position is able to support projects within QC Operations, e.g. implementation of iLABs projects, harmonization / standardization of processes.

Qualifications / Requirements:

• A minimum bachelor's degree or equivalent education 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 lead.
• High level commitment to meeting customer expectations as determined by the eLIMS CoE lead.

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