QC Microbiology Analyst is required for 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. 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.
The QC Microbiology Analyst will:
o Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
o Perform environmental monitoring sampling and testing of facilities, equipment, and critical utilities.
o Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
o Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
o Perform growth promotion of media and microbial identification testing.
o Qualify as trainer for specified methods, provide training to less experienced staff.
The QC Microbiology Analyst will require:
o Bachelor’s Degree in a relevant area
o A minimum of 3 years experience within the Pharmaceutical Industry in a FDA/EMEA regulated laboratory
Call Amparo in LSC on 0214777 329 to discuss this QC Microbiology Analyst role in more detail or apply directly via this advert