Job Description
STEM Recruitment Partners are working with a leading company to fill an exciting opportunity for a QC/QA Specialist (Technical Lead) at their Life Science business in Mullingar, Co. Westmeath, Ireland. About the Company The company is new to the Mullingar region, having just launched their site after successful growth over the past few years. They renowned for developing and manufacturing biopolymers for medical device and pharmaceutical companies. They have strong growth plans in place for the next few years so it is a very exciting time to join the company. Salary & Benefits Salary up to €65,000 DOE plus benefits which include health insurance for you and your family, pension contribution, excellent bonus scheme and many other benefits. About the Role This critical, permanent role reports to the Quality Manager and involves providing technical leadership, performing analytical and quality tasks, and driving continuous improvement initiatives within a GMP-compliant environment. Key Responsibilities: Conduct independent analytical testing, method optimization/validation, and technology studies or method transfers for excipients and raw materials. Adhere precisely to methods, protocols, and SOPs. Design and execute experiments independently. Prepare, review, and critique study protocols, project reports, and related documents. Communicate data and technical issues, and independently resolve technical problems. Provide mentorship and training to quality analysts. Lead analytical troubleshooting for methods and instruments. Plan, direct, and implement system and process improvements. Prepare and implement SOPs, methods, and quality systems. Review and analyze data for compliance with protocols, SOPs, and GMP. Perform self and peer reviews for data accuracy and compliance. Lead non-conformance, change control, CAPA, OOS investigations, and customer complaints. Communicate with vendors for instrument IQ/OQ scheduling. Monitor key quality metrics, prepare reports, and present findings to senior management. Identify and implement compliance requirements per regulatory bodies. Provide training and mentorship on GMP compliance and quality assurance processes. Qualifications: Minimum B.Sc Degree or equivalent, or a combination of relevant education and experience. 4-6+ years of experience in an analytical testing laboratory within a QMS and GMP environment. Preferred Skills: Technical experience with analytical techniques such as GC, ICP-MS, Karl-Fisher, potentiometric titration, GPC, polarimetry. Experience in QMS activities, including non-conformances, OOS investigations, root cause analysis, and change controls. Mentorship and training experience. Strong time management, project management, and technical writing skills. Experience with 5S or lean lab culture. Collaborative team player with the ability to train junior staff. Skills: QC Quality control GC