QC Microbiology Analyst

QC Microbiology Analyst

For major pharma company based in Swords, Co Dublin

This is a shift role, working 4 days on & 4 days off, 7am to 7pm (Days) shift premium is 20%

QC Microbiology Analyst role is a critically important activity to ensure efficient and effective compliant, qualification, and operation of the new strategic Drug Substance facility. This tremendous opportunity will be responsible for qualifying the Microbiology Quality Control lab and the verification 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.

The full QC analytical scope will incorporate micro, chemistry, bioassay, raw materials, stability, and in-process. Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc.) will allow the candidate challenge current thinking in designing for the future. The candidate will have responsibilities in the qualification of methods.

• Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI sampling & testing, growth promotion testing, TOC & Conductivity testing, in-process product testing, final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements
• To integrate and complete all documentation 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, bioburden testing, EM testing, absence of contamination testing and identification testing
• Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards
• Support the laboratory testing schedule to achieve an efficient QC system
• Receive and manage samples that come into the lab for testing
• Solution preparation, cleaning, routine equipment maintenance and system set-up
• Writing and update of SOPs
• Calibrate and maintain all designated laboratory instruments
• Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures
• Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations
• Ensure that cGMP standards are maintained at all times
• Delivery of area performance to meet or exceed performance or quality goals
• Promote and participate in the implementation and maintenance of the relevant safety programmes
• Participate and comply with the Quality Management System requirements

Experience

• 1-3 years industry experience with significant knowledge and experience working in a Microbiology Laboratory
• Experienced in testing as per the pharmacopeia’s
• Working knowledge of QC Systems (eLogs, Electronic Lab Notebook, LIMS etc.)