QC Analyst

Life Science Consultants Ltd

Cork

Looking for a new opportunity in QC in Cork ? A QC Analyst is required for a Biopharmaceutical company that 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. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market. This role offers you a chance to work in a state of the art facility, in an innovative Biotechnology company, with excellent career development opportunities and a clear and committed patient focus. The team is divided into 3 sub-teams QC Analytical; QC Microbiology and QC In-Process. The role could potentially lie within any of these sub-teams depending on experience and requirement. The QC Analyst will: Microbiological testing performed by the lab incl: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & BIs. Anaytical testing performed by the lab incl: HPLC, SDS, FTIR, UV, plate based assays; capillary electrophoresis. Testing of finished product, raw materials, packaging and stability. Perform primary review of QC raw data and trend results. Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies. Develop, optimize, validate and troubleshoot analytical test methods. Draft QC SOPs. Act as technical resource (SME)and train other analysts in areas of expertise. Conduct and document laboratory investigations to completion. Interact directly with regulatory agency inspectors during audits. The QC Analyst will require: B.S. in a scientific discipline. 3 years of relevant laboratory experience. Knowledge of cGMPs. Shift work may be required. Call Amparo in LSC on 0214777 329 to discuss this QC Analyst role in more detail or apply directly via this advert. This job originally appeared on RecruitIreland.com.

2590 days ago