Job DescriptionQuality Assurance SpecialistCarlow is seeking a Quality Assurance Specialist to join its quality team, focusing on validation and new product introduction (NPI). In this vital role, the specialist will be responsible for overseeing the introduction of new products and ensuring the quality of validations executed at the Carlow facility. Key responsibilities include providing quality oversight and approval of validation documents related to a sterile facility, including cleaning validation, and supporting the introduction of new products while ensuring compliance with corporate and regulatory manufacturing standards. The specialist will collaborate with cross-functional teams, particularly Technical Engineering, to meet manufacturing, technical, and regulatory requirements.Candidates must have experience with equipment and process validation, as this is crucial to the role's responsibilities. Additionally, familiarity with sterile filling processes and equipment is essential. The position requires 3-5 years of experience in a quality role, ideally within a pharmaceutical manufacturing environment. This opportunity allows the successful candidate to contribute significantly to the development and manufacture of vaccines and biological products, ensuring high-quality standards within the Carlow facility.What you will do:Bring energy, knowledge, innovation, and leadership to carry out the following:Provide quality oversight and direction for the introduction of new products and validation activities.Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.Participate as a functional expert in the cross-functional team responsible for introducing products at Carlow.Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.Review and approve protocols and reports for technology transfer, method qualification, and method validation.Review documentation associated with new product, such as, QC Test Specifications, BOMs, and MES documentation.Support deviation Investigations and close out in a timely manner.Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.What skills you will need:In order to excel in this role, you will more than likely have:A Bachelor's degree or higher in a related Science discipline is preferred.A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.Strong Continuous Improvement Mindset.Strong report, standards, and policy writing skills.Experience with equipment and process validation.Familiarity with sterile filling processes and equipment.Proficiency in Microsoft Office and job-related computer applications.Experience or familiarity with Lean Six Sigma methodology is desired.Good collaboration skills and the ability to work effectively as part of a team to determine priorities.Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.Proven ability to drive the completion of tasks.Strong decision-making capability with a sense of accountability and responsibility.Demonstrated problem-solving skills.At our company, 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 Ireland to the world.Our Commitment to Ireland:Our Company Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse 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 the company’s top products, helping save and enhance lives in over 140 countries around the world.The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.As a company, we are committed to ‘Inventing for Life’ in all that we do. 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. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.So, if you are ready to:Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.Current Employees apply HERECurrent Contingent Workers apply HERESearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:01/21/2025*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.