QC Lab Services LIMS Specialist 1

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

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

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

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Johnson & Johnson and Legend Biotech USA Inc, have entered a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

We are seeking a highly skilled LIMS Specialist with extensive experience beyond basic end-user functionality with a proven track record in developing, implementing, and managing LIMS solutions within the biological or pharmaceutical industries. This individual will play a pivotal role in supporting system configurations, data integrity, and compliance while collaborating with cross-functional teams. Strong analytical skills and the ability to communicate effectively with team members are crucial for addressing complex issues and driving continuous improvement in laboratory operations

Responsibilities Include:

• Manage the administration of computerized systems, including LIMS and iLAB, ensuring user rights are appropriately assigned; provide training to new users and facilitate system access.
• Support the development and execution of electronic systems (LIMS, iLAB) and review/approval of MasterData in alignment with local requests.
• Collaborate with senior LIMS team members at the Raritan site during Global Forums and team meetings to address issues and provide effective solutions.
• Author, review, and approve controlled documents, ensuring compliance with operational standards.
• Assist in preparations for Health Authority Inspections and internal audits to uphold regulatory requirements.
• Complete all tasks in accordance with safety policies, quality systems, and cGMP standards.

Knowledge, skill, ability and experience required

• Strong understanding of current Good Manufacturing Practices (cGMP) related to the Quality Control (QC) laboratory, with the ability to identify gaps in processes or systems.
• Knowledge of compendial requirements (USP, EP, JP, etc.) relevant to QC functional areas.
• Demonstrated proficiency in technical writing, ensuring clarity and accuracy in documentation.
• Proficient in using Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.

Qualifications

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 in the biological and/or pharmaceutical industry is required.
• A minimum of one (1) year of LIMS experience is required, specifically in areas such as system configuration, data integrity management, electronic record management, workflow automation, and compliance reporting.
• Ability to train new LIMS users and provide ongoin