QC Microbiology Analyst

Job DescriptionQC Microbiology Analyst For major Pharmaceutical company based in Dundalk. The QC Microbiology Analyst role is a critically important activity, ensuring efficient and effective compliant design, construction, qualification, and operation of the new strategic Biotech Drug Substance facility. This position will be responsible for qualifying the Microbiology Quality Control lab and the transfer of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods.

This person will be key in the layout of the lab testing flow to ensure the process is streamlined and in line with lean principles. Additional development opportunities within the micro and chemistry lab will be strongly considered to recognize the tremendous value of knowledge / experience gained by the candidate during the project phases. The facility will utilize the latest innovations in technology and automation to.

The candidate will work with a high performing cross functional team of talent sourced from across the biotechnology industry. Together, the team will build the future of Biotech through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team. The full analytical scope of QC will incorporate microbiology, mycoplasma (DNA) analytics, analystical chemistry, bioassay, raw materials, stability and in-process testing.

Advanced analytical methods (rapid ID techniques, paperless lab, etc) will allow the successful candidate to work in a innovative and stimulating environment which encourages communication and ideas for the future. The candidate will have responsibilities in analytical transfer and qualification of methods. The motivation to be an inspiring member of a high performing team.

The desire to continuously learn, improve and develop. Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers. Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidmetric and MCS rapid endotoxin testing in compliance with GMP requirements.

To integrate and complete all documention on time and be familiar with LIMS. To train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, EM testing, absence of bioburden testing and identification testing. Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.

Skills: Microbiology Environmental Monitering Endotoxin Bioburden TPBN1_IJ