QC Analyst Biotech manufacturing Sligo Have you ever wondered what it is like to work in a Biotech before it goes into full scale production? Well this could just be the role for you. This company are small at present but have a massive global presence in the biotech space. Currently they are recruiting a QC Analyst for their facility. The successful candidate will be responsible for utility qualification, utility testing, environmental monitoring, product testing and ideally have prior experience in Elisa, PCR, Assay or bioassay as well as some method validation. Role *Understand and support testing of product samples including raw materials, intermediates and finished goods as well as environmental and clean utilities samples. *Performance of laboratory tests as per standard operating procedures. *Recording of analytical results accurately. *Operation, maintenance and calibration of laboratory instruments. *Generation or updates of necessary documentation to support the QC laboratory, i.e. procedures, work instructions and protocols. *Execute microbiological/product method validations as needed for product and clean utilities qualification program. *Perform bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs). *When required, perform virus neutralization and viral titration sample analysis in accordance with standard operating procedures (SOPs). *Perform or support the sample analysis for microbial identification. *Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT. *Present analytical data/trend reports clearly and concisely to management. *Sampling and testing to support qualification and re-validation of utilities and cleanrooms. *Ensure cGMP & GLP standards are maintained and adherence to schedules to meet regulatory and business requirements. *Support the execution of pilot scale vaccine manufacturing processes for proof-of-concept and optimization trials. Requirements *Honours Bachelors degree in a technical discipline (e.g. biochemistry, chemistry, biotechnology, biopharmaceutical science). A Bachelors degree in science with additional significant microbiology lab experience will be considered. *Min 3 years of industry experience within a GMP laboratory. *Significant microbiological skills and understanding will be considered an advantage. *Experience with vaccines would be preferable particularly in the area of viral titrations, ELISA and PCR testing. *Must have experience in authoring, reviewing and execution of method validation studies and reports. *Experience in laboratory investigations, deviations and change controls will be considered an advantage. Skills: PCR ELIZA ASSAY
