Job DescriptionOur Carlow Site has immediate opportunity for a QC Bioassay Analyst / Senior Tech QC to join our Quality Operation Laboratory. You will operate as part of the QC team performing the allocated testing and laboratory-based duties and although it is preferable that Analysts have Immunoassay and cell culture experience, we are open to considering applicants that fulfil the duties as detailed below.Reporting to the Bioassay Manager / Associate Director, and works a shift pattern (early, late 7-3 / 2:30-10:30)Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.What you will do: Bring energy, knowledge, innovation, and leadership to carry out the following:Perform and review a range of techniques such as immunoassays, cell-based potency bioassays, ELISA and aseptic techniques as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP.Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.Ensure that all Quality Systems within the department are adhered to daily.Operate as part of the QC team performing the allocated testing and laboratory-based duties.Ensure timely completion of all assigned data processing and reviewing.Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures.Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.Review, approve and trend test results where applicable,Participate in the laboratory aspects of OOS investigations.Provide support with audit/inspection requirements to ensure department compliance/readiness.Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc, May be required to perform other duties as assigned.What skills you will need:In order to excel in this role, you will more than likely have:Bachelor’s Degree or higher preferred; ideally in a science related discipline.Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.Knowledge of cGMPLaboratory Quality Systems experienceProficiency in Microsoft Office and job-related computer applicationsReport, standards, policy writing skills.Understanding of Lean Six Sigma Methodology preferred.Immunoassay, ELISA and cell culture experience preferable.Great communicator, decisive decision-maker with a proven ability to deliver excellence.Ability to participate in highly effective teams.Desire to continuously learn, improve and develop.Willingness to support the team and a strong focus on delivering excellence.High personal integrity, credibility, energy, and flexibility.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:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:12/13/2024*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.