.. initiative.Honesty, integrity, reliability, commitment, and punctuality.A collaborative spirit and proven teamwork skills.Board Meetings:There will be four to six board meetings and four to six sub-committee meetings annually. Meetings are held at Talk To Tom, Pugin Court, St Michaels Road, Gorey, Wexford .. read more
Overview An exciting opportunity to become part of a dynamic team responsible for the design, development and manufacture of Reagent Kits. The team is responsible for a diverse range of activities including analytical development, product development including verification and validation using LC-MS/MS technology, manufacturing including lyophilisation, quality control and on-market support. Responsibilities The successful candidate will:Transfer manufacturing processes from development into manufacturing for reagent kits.Carry out quality control testing in accordance with defined processes and laboratory procedures including but not limited to finished product testing and raw material testing.Handle stability studies for new and on market Reagent Kit products.Perform and plan analytical validation studies in the laboratory for Reagent Kit products.Perform and plan process validation studies for the manufacture of Reagent Kits.Manufacture of Reagent Kits.Handle the laboratory instrumentation and schedule and perform maintenance, calibrations, PMS etc as required.Generate / review BMRs, procedures, test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.Plan day to day activities, ensure sufficient supplies of materials to carry out tasks etc and organise all proficiency testing within the laboratory.Ensure that all work is compliant within the existing quality processes for both In Vitro Diagnostic and Research Use Only.Perform investigative work as required by the organization to support Reagent Kits.Maintain detailed records.Create and revise laboratory SOPs as required. Qualifications Experience required:A degree or equivalent experience in a scientific subject with a strong chemistry component and / or equivalent years' experience in industry.Proven experience of working in a laboratory with analytical equipment such as HPLC or UPLC. Practical experience of LC/MS/MS would be a distinct advantage.Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).Knowledge of the design control process and/or demonstrable effective experience in a QC role and/or regulated environment.Familiarity with basic laboratory procedures including gravimetric and volumetric preparations.Experience using SAP would be an advantageMicrosoft excel training or substantial experience utilising Excel is required. The ability to use Macros is desirable.Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.Experience Desired: Product development, design, and product transfer experience desired. Experience working in an R&D environment (pharmaceutical or medical device) or a Clinical laboratory would be advantageous.Understanding of the requirements of quality management systems- ISO13485 & 21CFR820.Knowledge of Non-Conformance, Change Control, and CAPA systems.Freeze Drying experience an advantage but not required.Proficiency / skills required:The person must:Be highly goal-oriented and organized and be able to thrive in an atmosphere of shifting demands and priorities.Be able to work independently and as a member of a cross-functional team, to multi-task and prioritise to meet high expectations and tight deadlines.Must be results oriented and highly focused.Have technical writing and reviewing skills.Have excellent attention to detail. Traceable recordkeeping and ability to write and follow standard operating procedures / methods. Ability to work on one owns initiative and to adhere to GLP.Be driven and flexible who can allocate time and resources efficiently, effectively prioritize, and continually seek ways to improve individual and corporate efficiency.Excellent documentation and communications skills- Possess excellent oral and written communication skills as well as technical writing and reviewing skills.Proficiency with standard Microsoft computer programs. Company Description Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality. Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow. Waters Wexford:People create the Waters difference. By engaging with our talented and diverse workforce we continuously evolve, develop and enhance our state-of-the-art manufacturing and development facilities at Wexford. Deliver benefit at the world’s leading speciality measurement company where our advanced technologies include chromatography columns, solid-phase extraction devices, mass spectrometry instruments, software and reagent kits. The Wexford operation is a strategically important component of Waters Corporation’s global manufacturing footprint.