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Quality

Analyst eLIMS CoE

  • 标题 Analyst eLIMS CoE
  • 功能 Quality
  • 子功能 Customer/Commercial Quality
  • 类别 Analyst, Customer/Commercial Quality (P4 - E24)
  • 工作地 Beerse, Antwerp, Belgium
  • 发布时间
  • 申请ID 2406183324W
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描述

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!

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/.

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 Operational Excellence, LIMS Master Data Analyst, QC Operations, works within the eLIMS master data team (EMEA Small Molecule hub) and independently 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, builds and handles any system related documents, and identifies and drives process improvements. This position is able to work well with IT and speaks business language to customers.

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. The Analyst is able to support the CAR-T project within the CoE, e.g. Harmonization / standardization of processes.

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 high-quality master data.
  • Builds, updates, reviews & approves Master Data for all supporting sites.

40-50%

  • 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 pre-identified difficulties and aspirations, address them and achieve the end result of effective solutions
  • Maintains system related documentation (procedures, events, etc) with the appropriate applications (TruVault, Trackwise/COMET, Confluence, q-Test or any other crafted system
  • 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

资格

Qualifications - External

Qualifications

1.                  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.

2.                  Ability to balance multiple issues, coordinate activities, prioritize, and raise to management when appropriate.

3.                  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.

4.                  Proven strong written and verbal communication skills (Basic in English – B2) and the ability to develop and provide training to colleagues and partners.

5.                  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.

By joining Johnson&Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well as your mind. When you work at Johnson&Johnson you can touch over a Billion of lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson&Johnson means that “YOU belong”!
For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential. No matter who they are.

Pay Grade 24

Primary Location; Beerse, Belgium

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