QC Specialist Separations

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Ringaskiddy, Cork, Ireland Job Description: We are searching for the best talent for a QC Specialist – Separations . Purpose We are looking for a QC Specialist – Separations to join our Quality Control team. In this role, you will provide technical expertise and support for Quality Control laboratory activities within a regulated pharmaceutical manufacturing environment. You will work closely with laboratory teams and cross-functional partners to support analytical testing, equipment qualification, method transfer activities, investigations, and continuous improvement initiatives. The role requires sound technical knowledge of analytical techniques and laboratory equipment in one or more of the following areas: Chemistry, Biochemistry, or Microbiology. Previous supervisory experience in an IMB/FDA-regulated environment is required. You will be responsible for Working closely with the QC Manager and laboratory teams, you will provide technical support for testing operations and contribute to the delivery of compliant and efficient Quality Control activities. Key responsibilities include: Supporting day-to-day testing operations Coordinating qualification of analytical equipment and associated testing functions, including technologies such as HPLC, Spectrophotometry, Nephelometry, and Total Organic Carbon systems Coordinating sampling and testing activities during plant and laboratory utility qualification Planning and coordinating analytical method transfer activities for relevant New Molecular Entities (NMEs) Coordinating analytical testing and sampling activities for raw materials, utilities, in-process samples, final bulk, and finished products Supporting implementation of analyst training programs Reviewing and approving laboratory data and Quality Control investigations Reviewing specifications and supporting associated LIMS scheduling activities Reviewing and approving deviations, CAPAs, and Change Controls Planning and overseeing laboratory projects, including method transfers and equipment qualification activities Identifying and supporting laboratory process improvements Training laboratory personnel on specific analytical technologies Providing technical support on analytical technologies Supporting lean initiatives related to laboratory operations, including test execution, documentation updates, and equipment qualification activities Presenting analytical and technical information clearly and concisely to internal stakeholders and regulatory inspectors Maintaining awareness of analytical technology developments and compliance trends The role partners with other departments and Team Leaders to help ensure Quality Control activities are completed effectively and in accordance with GMP requirements. Qualifications / Requirements Experience Minimum of 3 years of experience within the pharmaceutical industry Prior supervisory experience working in an IMB/FDA-regulated facility Knowledge of FDA and EMA regulatory requirements applicable to biologics and/or pharmaceuticals Technical