eLIMS QC Analyst

at  Johnson Johnson

Johnson & Johnson is currently seeking an eLIMS QC Analyst to join our Quality Control department located in Ringaskiddy, Co. Cork.
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/.
Are you passionate about applying your expertise in eLIMS to enhance lab operations and support innovative projects? Do you thrive on solving complex technical challenges? Are you excited about the opportunity to collaborate with various departments to improve efficiency?
What you will be doing:
This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures at Janssen Sciences Ireland (JSI) as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all activities are completed in an efficient manner. We have an exciting opportunity for an eLIMS Analyst QC Lab Services. This individual will join the Lab Services Team supporting the eLIMS System.

What impact you will also have:

• Provide level 1 support to local users, monitor and resolve eLIMS Support tickets.
• Create LIMS template builds, LME methods, Master Data updates etc.
• Support key projects as required e.g. Deployment of paperless lab initiatives to QC labs, shutdown activities.
• Develop and maintain local SOPs aligned with global SOPs.
• eLIMS point of contact for Regulatory Inspections.
• Troubleshoot and collaborate with Global Team on local issues.
• Writes, executes, reports and reviews documents so as to ensure that all information is for cGMP use.
• Achieves competency in JSI eLIMS methods and procedures.
• Trains other QC analysts in procedures when required.
• Executes troubleshooting of equipment and its associated software.
• Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards.
• Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
• Anticipates and plans for future requirements in the area.
• Deals with non-conformances/ deviations in an accurate and timely manner.
• Deputizes for the QC Team Leader as appropriate.

QUALIFICATIONS

We would love to hear from you, if you have the following required requirements:

Education:

• A third level qualification in a scientific/technical discipline required.

Experience and Skills:

• A minimum of 2 years experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.
• Continuous improvement and innovation.
• Collaboration and teamwork.
• Integrity and customer focus.
• Interpersonal and communication skills.
• Adaptability and attention to detail.
• Results-driven.

What type of mark will YOU make?
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 and your mind. When you work at Johnson & Johnson you can touch over a Billion 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 “YOU belong”!
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong

Please refer the Job description for details