QC Compendial Analyst - Vaccines

Job description

Job Description Ireland – The Company: Within our Company in Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from our Company in Ireland to the world. Our Commitment to Ireland: Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of our Company’s top products, helping save and enhance lives in over 140 countries around the world. As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network. An exciting opportunity is now available for a Quality Control Analyst to join and contribute to our mission of using leading-edge science to save and improve lives around the world. Bring energy, knowledge, innovation to carry out the following: Operate as part of the QC team performing the allocated testing and laboratory-based duties. Serve as a testing subject matter expert within the QC department. Participate in OOS investigations and support troubleshooting activities. Attend daily QC Tier meetings and communicate testing progress, deviations, and any potential cGMP or compliance concerns. Contribute to the drafting, revision, and rollout of operational procedures, training materials, and maintenance procedures for quality systems. Conduct peer review of testing documentation and ensure data integrity compliance and achievement of QC Right First Time KPIs. Support laboratory readiness, audit readiness, and audit participation. Assist with laboratory equipment qualification and analytical method technical transfer, verification, and validation. Maintain laboratory equipment, perform cleaning activities, and support vendor maintenance tasks. Complete CMMS tasks in conjunction with equipment maintenance. Contribute to a continuous improvement culture through problem-solving and troubleshooting. Demonstrate a commitment to ongoing learning and personal development. What skills you will need: Degree qualification in a relevant discipline such as Science, Quality, or Technical. Minimum of 2 years of laboratory experience, including sampling, testing, and reporting. Motivated team player with the ability to contribute to a high-performing team and support the future of our company Dundalk. Strong desire to continuously learn, improve, and develop. Flexible, self-motivated, and adaptable. Effective communication and presentation skills. Proficient in IT applications, including Microsoft Office. Strong critical thinking and problem-solving skills. Good knowledge of cGMP, GLP, Pharmacopoeias (USP, Ph. Eur.) and Quality Management Systems. Good understanding of testing requirements for raw materials, primary packaging materials, drug product, and drug substances. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Required Skills: Corrective Action Management, GMP Documentation, GMP Testing, Pharmacopoeias, pH Testing, Quality Control Management, Quality Manuals, Raw Materials, Root Cause Analysis (RCA), Standard Operating Procedure (SOP) Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): na Job Posting End Date: 09/26/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.