Quality Control Analyst

Job description

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. Learn more at jnj.com. 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 Job Description: 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. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for the Quality Control Analyst position to be in Cork, Ireland. Purpose: This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures at CBIL as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner. As a Quality Control Analyst, you will: Achieve competency in CBIL laboratory methods and procedures. Trains other QC analysts in laboratory methods and procedures when required. Perform 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. Execute validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software. Write, executes, reports and reviews IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use. Perform routine and non-routine analytical testing activities. Review and approval (where appropriate) of laboratory test results. Ensure that testing and results approval are completed within agreed turnaround times. Write and reviews laboratory TMs, SOPs and WIs as directed by company policy. Ensure 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. Qualification/Requirements: A third level qualification in a scientific/technical discipline required. 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. 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! #RPOEMEA #LI-Onsite Required Skills: Collaboration, Customer-Focused, Innovation, Problem Solving, Strategic Thinking Preferred Skills: Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy The anticipated base pay range for this position is: €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. Additional information: 42,400 - 67,965