Quality Control Analyst

Johnson & Johnson; Cork; On-site; EUR 30,000 - 41,000; Full time

Job summary

Johnson & Johnson Janssen Sciences Ireland (JSI) seeks a QC Analyst to carry out testing procedures for GMP-compliant operations. The role involves validating methods, maintaining equipment, and supporting IQ/OQ/PQ activities while ensuring timely results and compliance with regulatory standards.

The successful candidate will have a third-level scientific qualification and at least 2 years' experience in a biopharma/regulated lab environment, with knowledge of FDA/EMEA guidelines and experience

Qualifications

• Third-level qualification in scientific/technical discipline required.
• Minimum 2 years' experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.

Responsibilities

• Achieve competency in Janssen Sciences Ireland (JSI) laboratory methods and procedures.
• Train other QC analysts in laboratory methods and procedures when required.
• Perform analytical testing activities related to method validation and technical transfer to ensure methods meet ICH, CFR USP and EP guidelines.
• Execute validation, operation, maintenance, calibration and troubleshooting of equipment and associated software.
• Write, execute, report and review IQ/OQ and PQ protocols to ensure equipment is qualified for cGMP use.
• Perform routine and non-routine analytical testing activities.
• Review and approve laboratory test results where appropriate.
• Ensure testing and results approval are completed within agreed turnaround times.

Education

Third level qualification in scientific/technical discipline

Job description

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

Roles and Responsibilities

• 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.
• Performs routine and non-routine analytical testing activities.
• Review and approval (where appropriate) of laboratory test results.
• Ensures that testing and results approval are completed within agreed turnaround times.
• Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
• 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.
• Maintains and develops knowledge of analytical technology as well as cGMP standards.

How to Succeed

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

This role offers a very competitive hourly rate. This contract will run for 12 months.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Application Process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.