Job DescriptionA fantastic opportunity has arisen for a Quality Assurance SpecialistThe Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor. The Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right first time, and to ensure compliance with cGMPs and regulatory requirements. This is a shift role (4 x 12hr extended days followed by 4 days off)What you will do:Be Responsible for review/approval of new and updated Master Batch Records / Electronic Batch RecordsReview and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures. Provide presence on the shop floor to support compliance and data integrity.Review and approve new and updated SOPs/ Work Instructions and Controlled Job AidesActively participate in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution.QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation.Participate as the quality member on cross functional projects.Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration ProgramProvide support to internal audits and regulatory inspections.Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.Drive continuous improvement and utilise problem solving tools and MPS (our company's Production Systems) Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues.What skills you will need:In order to excel in this role, you will more than likely have:Bachelor’s degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.Evidence of leadership skills coupled with good oral and written communication skills. Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.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.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:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:03/21/2025*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.