Analyst Elims Coe
il y a 1 semaine
Analyst eLIMS CoE - QC Operations:
Are you great at organizing knowledge and connecting dots? Do you enjoy having things in order and assuring that everything makes perfect logical sense? Are you the kind of person who is ready to find solutions to complex problems and stays level-headed when request pile up? Would you like to use these skills to improve lives of cancer patients at the frontier of medical research? If the answer to these questions is yes, we are looking for you
Description
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 EMEA, preferably in Belgium or the Netherlands supporting on-site activities in CAR-T Belgium.
Position Summary:
The Analyst collaborates with more than one customer at supporting J&J sites including support of the CAR-T project to fully understand the Master Data requirements and review all configurations for accuracy and completeness.
This position takes ownership by supporting the base business requests for all other supporting sites (Geel, Beerse, Beerse DPDS, Latina, Cork, Raritan, Gurabo) 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.
The Analyst is encouraged to raise any issues and understand the impact towards other customers when changing / updating existing Master Data.
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 iLAB projects, harmonization / standardization of processes.Major Duties and Responsibilities:
50-60 %
- Leads and coordinates the incoming requests into the mailboxes to support base business sites. Assess the requests, check the accuracy of forms and the request, follow up with site for transparency or challenge when needed.
- Understand the changes to specifications and translate that into elims master data. Understanding of the iLAB processes, including the master data design file to ensure accurate set up of tests.
- Proven understanding of the site process and product flows to ensure accurate and highquality master data.
- Builds, updates, reviews & approves Master Data for all supporting sites.
- Participates in system related project activities of CAR-T as requested by the CoE lead including review and testing of system updates; Coordinates eLIMS activities with the local labs
- Consults with management, employees, and departments of CAR-T to deep dive on preidentified difficulties and aspirations, address them and achieve the end result of effective solutions
- Participates in pre CoC/ Kick off meetings, own the implementation activities of a change control.
- Responsible for communicating business related issues or opportunities to next management level
- Builds test scripts for user acceptance testing
- Provide feedback to CoE team lead regarding eLIMS activities performance
Qualifications:
Qualifications - External:
Qualifications
- A minimum bachelor's degree or equivalent experience or education is required. A minimum of 3-5 years of working experience 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 balance multiple issues, coordinate activities, prioritize, and raise to management when appropriate.
- They must have broad knowledge and experience with cGMPs, regulations, risk management. Previous Quality Systems experience is required. Knowledge of/familiarity with other appropriate lab systems (Empower/SDMS/LES) is preferred.
- Proven 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 positive relationship with local laboratories. Maintain a clear line of communication with the eLIMS CoE lead. High level dedication to meeting customer expectations as determined by the eLIMS CoE lead.
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