LSC have a great contract opportunity for a QC Analyst to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use. If you have 3+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you ABOUT THE PROJECT - KEY RESPONSIBILITIES: Perform primary review of QC raw data and trend results. Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies. Draft and update QC Standard Operating Procedures (SOPs). Act as a technical subject matter expert (SME) and provide training and support to other analysts in areas of expertise. Evaluate analytical and microbiological results against defined acceptance criteria. Conduct and document laboratory investigations through to completion. Maintain the laboratory in a constant state of audit and inspection readiness. Interact directly with regulatory agency inspectors during audits and inspections. Interface with other BioMarin functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required. Other duties as assigned. ABOUT YOU - ARE YOUR SKILLS A MATCH? BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience. Or MSc with 3+ years of relevant cGMP laboratory experience. Excellent written and verbal communication skills. Strong customer focus, with personal accountability for speed, quality, and accuracy of delivery. Self-motivated, with the ability to work under pressure in a fast-paced environment. Team oriented, with active participation in team development and continuous improvement, including standard work and 5S. Demonstrated success in achieving goals as part of a high performing team in a growing organisation. Proven adaptability and flexibility to support an evolving operational environment. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply Apply via this advert or contact Kathy Gillen at LSC on if you have any more questions about this role Skills: QC Analyst Quality Control Pharmaceuticals Shift Science Manufacturing Process