Quality Control Analyst IP, Ringaskiddy

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 toachieve 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.

Responsibilities

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 and 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

Anticipated Base Pay Range€42’400.00 - €67’965.00

Benefits In addition to base pay, we offer the following benefits: an annual bonus with set target (% of pay) depending on pay grade/location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well‑being&career growth | Johnson&Johnson Careers.

This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

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