Quality Control Analyst - Bioassay

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality

Job Sub Function: Quality Control

Job Category: Professional

All Job Posting Locations: Ringaskiddy, Cork, Ireland

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Job Description

We are searching for the best talent to join us as a Quality Control Analyst - Bioassay 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 bioassay 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 bioassay 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.

You will be

• Performing routine and non routine analytical and bioassay 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 written and verbal communication skills
• Strong attention to detail, problem solving ability, and analytical thinking
• Ability to work effectively in a collaborative, cross functional environment
• A results and performance driven, adaptable, and flexible approach

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

The anticipated base pay range for this position is: €42.400,00 - €67.965,00