QC Lab Services LIMS Specialist II

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)

Education


* A minimum of a Bachelor's Degree in science or equivalent technical field is required.

Required


* A minimum of two (2) years of experience within a biological and/or pharmaceutical industry is required with at least one (1) year of LIMS experience.


* Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.


* Experience with electronic systems such as LIMS and iLAB is required.


* Excellent written and oral communication skill are required.

Preferred


* Previous work experience in Cell and Gene Therapy is preferred.


* Experience in a Quality Control setting is preferred but not required.


* Detailed knowledge of routine and non-routine Environmental Monitoring testing and sampling methods, techniques and related equipment is preferred.

Other


* This position is located in Raritan, NJ and may require up to 10% of domestic travel...