Quality Control Analyst IP

We are searching for the best talent to join us as a Quality Control Analyst IP at Janssen Sciences Ireland (JSI) in Ringaskiddy, Cork, Ireland.

Purpose

In this role, you will be responsible for carrying out Quality Control laboratory activities related to QC IP testing, laboratory utilities, and equipment in compliance with Good Manufacturing Practice (GMP). You will partner closely with cross‑functional teams to ensure QC testing activities are executed efficiently, compliantly, and in alignment with regulatory expectations and company quality standards. Through this work, you support product quality, regulatory compliance, and continuous improvement across the site. You will need to achieve and maintain competency in JSI laboratory methods, procedures, and QC IP technologies, and training other QC analysts when required. Environmental, Health & Safety compliance is essential - you will need to comply with the company's Environmental, Health & Safety Policy, Safety Statement, associated EHS procedures, local legislation, and duties outlined in the site EHS Manual.

As a Quality Control Analyst IP, you will be responsible for:

• Performing routine and non‑routine analytical and QC IP testing, including method validation and technical transfer activities in line with ICH, CFR, USP, and EP guidelines
• Executing validation, operation, maintenance, calibration, and troubleshooting of laboratory equipment and associated software
• Writing, executing, reporting, reviewing, and approving IQ/OQ/PQ protocols to ensure equipment is qualified for cGMP use
• Reviewing and approving laboratory test results (where appropriate) and ensuring testing and approvals are completed within agreed turnaround times
• Writing and reviewing laboratory Technical Manuals (TMs), SOPs, and Work Instructions (WIs) in accordance with company policies
• Managing non‑conformances and deviations accurately and in a timely manner, ensuring compliance with product licence commitments, cGMP, and company quality standards
• Acting as an active member of the QC group by supporting team activities, communicating issues to the QC Team Leader and Manager, deputising when required, and contributing to future planning and continuous improvement initiatives

Qualifications / Requirements

• A third‑level qualification in a scientific or technical discipline
• A minimum of 2 years' experience in a laboratory testing environment within the biological and/or pharmaceutical industry
• Demonstrated knowledge and testing experience in an FDA / IMB‑approved QC laboratory
• Knowledge of FDA and EMEA regulatory requirements applicable to biologics and/or pharmaceuticals
• Strong analytical, problem‑solving, and decision‑making skills
• Excellent written and verbal communication skills
• High attention to detail with a results‑ and performance‑driven mindset
• Ability to work effectively as part of a collaborative, cross‑functional team

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here's what you can expect:

• Application review: We'll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country‑specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we'll invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process!

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