QC Analyst - Separations

ICH, CFR, USP, EP, and cGMP?

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 QC testing activities are completed in an efficient manner.

What impact you will also have:

• Achieves competency in JSI laboratory methods and procedures.

• Trains other QC analysts in laboratory methods and procedures when required.

• Performs analytical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR USP and EP guidelines.

• Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.

• Writes, executes, reports and reviews IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use as well as writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.

• Performs routine and non-routine analytical testing activities as well as review and approval (where appropriate) of laboratory test results.

• Ensures that testing and results approval are completed within agreed turnaround times and that 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.

• Maintains and develops knowledge of analytical technology as well as cGMP standards.

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.

• Foster continuous improvement and innovation.

• Promote collaboration, teamwork, and effective communication.

• Uphold integrity and customer focus.

• Partner with and interface across all departments.

• Demonstrate adaptability, problem-solving, and attention to detail.

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.