Senior QC Analyst – Analytical Laboratory

About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Job Purpose The Senior QC Analyst will be part of the Quality Control Testing Hub within a state-of-the-art single-use, multi-product biologics facility in Dunboyne, County Meath, Ireland. The role will support laboratory start-up activities and routine Quality Control testing, ensuring compliance with cGMP, corporate procedures, legal requirements, quality guidelines, and market authorisation requirements. The QC Senior Analyst will work across site self-directed work teams and hub teams to identify and resolve issues, support operational readiness, and contribute to Quality, EHS, Learning, and Continuous Improvement objectives. The role will involve biological, chemical, and physical analysis using state-of-the-art laboratory instrumentation and computerised systems. The successful candidate will have strong analytical laboratory experience within the biopharmaceutical industry, including UPLC, Capillary Electrophoresis (CE), PA800, deviations, compliance, and raw materials testing. The role will also support stability testing, drug substance testing, and validation activities. Requirements Key Responsibilities Support the Quality Control testing function and ensure compliance with cGMP, corporate procedures, legal requirements, quality guidelines, and market authorisation requirements. Responsible for the release of incoming goods, outsourced production and packaging products, and products and processes in accordance with established quality procedures and regulatory requirements. Conduct and support biological, chemical, and physical analyses using laboratory instrumentation and computerised systems. Perform analytical testing associated with UPLC, Capillary Electrophoresis (CE), PA800, and other applicable analytical methods. Support stability testing, drug substance testing, and validation activities. Review analytical data, documentation, and results to support the quality release of materials and products. Support deviation investigations, compliance activities, troubleshooting, and problem-solving within the laboratory. Provide advice on and support improvements to quality-related issues to ensure optimal quality of released products and processes. Understand quality requirements for the introduction of materials to site and communicate these requirements effectively to suppliers and relevant stakeholders. Apply Good Documentation Practices (GDP) and support implementation of documentation requirements at a local level. Support laboratory start-up, operational readiness, and continuous improvement activities. Work with moderate work direction while demonstrating the technical skills, knowledge, and independence required for the position. Identify and communicate quality and compliance risks within areas of responsibility and across the site. Create and implement strategies and plans to manage risk within Quality Control operations. Collaborate with Manufacturing Operations, Process Development Technical Services (PDTS), Quality, suppliers, and other cross-functional teams to deliver site objectives. Support product quality decisions by providing accurate and timely analytical information to relevant Quality stakeholders. Demonstrate strong project management skills and deliver activities within agreed timelines. Work effectively across self-directed work teams and hub teams to identify, investigate, and resolve complex issues. Support a culture of continuous improvement through the use of Lean and process improvement tools. Coach and mentor colleagues and self-directed work teams through complex problem-solving activities. Promote a culture of quality, safety, diversity, and inclusion. Demonstrate flexibility, self-motivation, and the ability to work both independently and as part of a team. Key Accountabilities: Strong project management and stakeholder management skills. Proven ability to deliver against tight timelines and manage multiple priorities. Excellent influencing, collaboration, communication, and teamwork skills. Strong troubleshooting, investigation, and problem-solving capabilities. Ability to challenge the status quo and demonstrate a continuous improvement mindset. Ability to think logically and proactively under pressure. Experience using Lean Six Sigma and other continuous improvement tools. Ability to support change management and act as a change agent within the organisation. Proven ability to work cross-functionally, meet and track schedules, and operate effectively within an interdependent work culture. Ability to establish stretch goals and support self-directed work teams in delivering their priorities. Demonstrated ability to give and receive constructive feedback. Excellent written and verbal communication skills. Strong organisational and time-management skills, including the ability to escalate issues appropriately. Commitment to maintaining high standards of quality, compliance, safety, and documentation. Educational & Experience Requirements Degree qualification in Science, Technical, Quality, Chemistry, Biology, Pharmaceutical Science, or a related discipline. Minimum 4 years of relevant experience in the biotechnology and/or pharmaceutical industry. No graduate-level candidates; relevant industry experience is required. Strong experience within a biopharmaceutical Quality Control/Analytical Laboratory environment. Experience with UPLC, Capillary Electrophoresis (CE), and PA800. Experience with raw materials testing and release. Experience with deviations, investigations, compliance, and quality systems. Experience supporting stability testing, drug substance testing, and analytical validation activities. Understanding of cGMP requirements for laboratory operations, systems, and compliance. Understanding of GMP, ICH, USP, and global compendial regulations and guidance. Demonstrated understanding of continuous quality/process improvement tools, such as DMAIC, Lean, 5S, etc. Proven ability to work cross-functionally and deliver against schedules and priorities. Excellent written and oral communication skills. Excellent time management and organisational skills. Ability to work independently with moderate direction as well as effectively within a team environment. Other Job Requirements: Onsite role based in Dunboyne, County Meath, Ireland. The successful candidate will work as part of a Quality Control team of approximately 28 people. This is a critical role within the Quality organisation supporting the establishment of the laboratory as a hub for specialised analytical testing and delivering value for patients. The role requires flexibility and the ability to work effectively within a fast-paced, start-up/multi-product biopharmaceutical manufacturing environment.