Yacht Life Sciences has a vacancy for an Analyst eLIMS CoE – Quality Control Operations to work at Janssen Biologics in Leiden.
As an Analyst eLIMS you work within the eLIMS Center of Excellence (CoE) and are 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. You independently create, maintain and review high quality data setups, integrate instruments and applications and translates specifications within the eLIMS system using current business processes. Also, as an Analyst eLIMS, you review and test system updates, create and manage any system related documents, and identify and drive process improvements.
As an Analyst eLIMS you take ownership by completing any incoming requests in a timely manner. In order to maintain high quality data. You are expected to fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete.
As an Analyst eLIMS you can develop training materials to enable sharing of knowledge within the team. You will train others in immediate team while continuously improving personal training and knowledge. You are able to support projects within QC Operations, e.g. implementation of iLABs projects, harmonization / standardization of processes.
- Minimum Bachelor's degree
- At least 2 years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS and Quality systems
- Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management
- Extensive other experience with analytical testing, quality control or IT is preferred
- Strong communication skills in Dutch due to the training aspect of this role
- Ability to manage multiple issues, organize activities, prioritize, and escalate to management when appropriate.
- Ability to develop and provide training to colleagues and partners
- Demonstrated 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.
- Ability to 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.
This concerns a secondment contract with Yacht to work at Janssen Biologics (J&J) for 1 year, extension is anticipated. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefits package in line with the seniority of the position (salary between 3200 and 4200 euro gross per 4 week period).
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
The Janssen Supply Group, a member of the Johnson & Johnson family of companies, is recruiting for an Analyst eLIMS CoE, QC Operations. Position can be based in any of our Operating Companies in Europe, preferably in Leiden
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.