* The QC Microbiology Analyst role is a critically important activity, ensuring efficient and effective compliant design, construction, qualification, and operation of our client's Drug Substance facility in Co. Dublin.
* 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 their lean principles.
* The candidate will work with a high performing cross functional team of talent sourced internally and from accross the biotechnology industry. Together, the team will build a Quality culture that delivers unconstrained supply, Right First Time to the patients through an inspired team.
* The candidate will provide support to the team and other analysts within the lab area, including training and guidance on their area of expertise.
Core Duties and Responsibilities:
* 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 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, water bioburden testing, E.M testing, absence of bioburden testing and identification testing.
* Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
* To update SOP's and write protocols as required and support the laboratory testing schedule to achieve an efficient QC system.
* Receive and manage samples that come into the lab for stability, in-process and release testing.
* Reagent preparation, cleaning, and routine equipment maintenance.
* Maintain good housekeeping and GLP within the laboratory; 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.
* Ensure training is current for all job functions performed and assist in training new QC Analysts on routine procedures and practices.
* Order, stock and receive laboratory supplies.
* 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.
* Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools.
* This position will be on days initially but shift work will be required.
Minimum Qualifications and Experience:
* BS in Engineering, Computer Science, or other technical degree.
* Degree qualification (Science/Quality/Technical).
* Preference Lean Six Sigma
* Ability to respond to changing priorities.
* Good aseptic technique and awareness of contamination control.
* 1-3 years industry experience with significant knowledge and experience in working in a microbiology lab unit and working with contract labs.
* Experience in compendial testing for water and environmental monitoring in clean room environments.
* Working knowledge of QC Systems (Empower, LIMS, Trending systems.)
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
(phone number removed)
Please note, we do not require agency assistance with this role