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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 ongoing support to the end users._**

+ Knowledge of cGMP regulations and FDA/EU guidance related to the manufacturing of cell-based products is crucial.

+ Excellent written and oral communication skills are required to effectively collaborate with cross-functional teams.

Preferred

+ Previous work experience in Cell and Gene Therapy.

+ Experience in a Quality Control setting.

+ **_Strong technical experience in LIMS administration, including: system expertise, system/equipment integration, computer system validation, navigating IT systems, strong problem-solving skills._**

+ **_Ability and flexibility to work on other shifts, evenings, and weekends as needed to support business requirements; this role requires a welcoming and accommodating approach to assist colleagues during business hours and late hours with LIMS-related requests and issues._**

Other

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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

\#CAR-T

The anticipated base pay range for this position is :

$69,500-$102,350

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.