Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Lab Services - Senior LIMS Specialist in Raritan, NJ!

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/ .

The QC Lab Services - Senior LIMS Specialist , CAR-T will support LIMS management for CAR-T site.

Responsibilities Include:

* Provide training to new LIMS users and grant access to system as needed

* Lead building electronic systems (LIMS, iLAB) for execution

* Lead building and approving MasterData as per the local request

* Manage computerized systems administration and user rights for LIMs and iLAB administration

* Represent the Raritan site in Global Forums/Team meetings to provide solutions to issues and challenges

* Author, review and approve documents as well as review and assess eLIMS related change controls and its impact to the site.

* Support Health Authority Inspections as well as internal audit inspections

* Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Knowledge, skill, ability and experience required

* Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems

* Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC

* Proficient in performing technical writing

* Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)