Eurofins CDMO Alphora Inc in Waterford, Ireland, is looking for a Quality Operations Specialist to enhance quality processes within the Molecular Cell Biology team. The role involves managing quality metrics, leading problem-solving initiatives, and ensuring compliance with GMP regulations. The ideal candidate will have a relevant life sciences degree and at least 3 years of experience in a regulated environment. Strong communication and organisational skills are essential. #J-18808-Ljbffr
Eurofins BPT Dungarvan are recruiting for a highly motivated Quality Operations Specialist to join our Molecular Cell Biology team. This is an exciting opportunity for a quality‑driven professional who thrives in a regulated environment and enjoys working across multiple quality system elements. In this role, you will play a key part in supporting the implementation, development, and continuous improvement of Quality processes within the Molecular Cell Biology Department and relevant supporting functions. As a Quality Operations Specialist, you will ensure robust systems and controls are in place to meet both customer expectations and regulatory quality requirements. You will also help lead, motivate, and develop the Molecular Cell Biology team in all aspects of quality, enabling them to respond effectively to evolving business needs while maintaining the highest standards of compliance. Key Responsibilities Manage and report all Quality Metrics for the Molecular Cell Biology team—including Exceptions, CAPAs, Change Controls, and SOPs—ensuring all actions are assigned, tracked, and closed in line with company compliance requirements. Review and approve all relevant Quality documentation for the Molecular Cell Biology department, such as Exceptions, CAPAs, SOPs, and quality/technical agreements. Lead and participate in cross‑functional risk assessments as required. Support and lead problem‑solving activities within the department, ensuring effective collaboration across functions. Ensure processes and systems are in place to complete Quality- and CAPA‑related project work and produce customer reports in a timely manner. Provide continuous feedback to team members regarding customer expectations, quality requirements, and process changes. Manage the completion of compendia update assessments for the department. Support department leadership in maintaining the quality of daily laboratory work and collaborate with team members to resolve any quality-related issues. Manage assigned customer queries, lead complaint investigations, and work with the team to identify and resolve root causes. Support internal and external/regulatory audits, including preparation, participation, responding to audit queries, and driving corrective actions to closure. Represent the Molecular Cell Biology department at Change Control Review Boards and equipment meetings, ensuring actions are assigned and tracked appropriately. Approve and maintain up‑to‑date laboratory SOPs within your area of responsibility. Identify opportunities to enhance quality, efficiency, and customer service, and support the implementation of continuous improvement initiatives. Establish and monitor key metrics related to quality and customer satisfaction/delivery, ensuring targets are met and trends are proactively addressed. Ensure all team documentation is accurate, complete, up to date, and compliant with company procedures. Communicate regularly with the team and supporting departments to ensure effective information flow throughout the organisation. Provide coaching and mentoring to improve understanding and compliance with quality standards. Review data in accordance with regulatory requirements, analytical procedures, and documentation standards. Review and accurately prepare reports for technological projects, ensuring confidentiality and timely delivery to clients. Qualifications Primary degree or equivalent in a related life sciences discipline At least 3 years’ experience in a GMP regulated environment Working knowledge of pharmaceutical quality systems Ability to work independently or as part of a team. Excellent report writing, communication and organisational skills. Quality oriented with the ability to consistently work to industry and client standards. Positive and tenacious approach to work. Highly organised, methodical and systematic approach to work. Passionate about quality and customer service. Good communication skills both internally and externally. Ability to understand clients’ requirements and to be able to devise and articulate the most appropriate solutions. #J-18808-Ljbffr
