Orion Group Life Sciences are currently recruiting a QC Microbiology Analyst
on behalf of our Multinational Biopharmaceutical Client based in Swords on an initial 11-Month contract with potential to extend.
Shift: Days On/ 4 Days Off. 12 Hour days. Shift Premium: 20%
• 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 in Swords.
• 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.
• To maximize the development opportunity, the candidate will be the key talent in analytical Microbiology techniques and in current Pharmacopeial methods.
Role Functions:
• 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.
• To update SOP's and write protocols as required.
• 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.
• 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.
Experience, Knowledge and skills:
• 1 to 2 years' relevant experience.
• Experience and critical skills in the area of expertise that add value to the business; ideally analytical microbiology, in a GMP setting.
• Knowledge of cGMP.
• Report, standards, policy writing skills required.
• Lean Six Sigma Methodology experience.
• Understand the specific responsibilities of all departments as they relate to one's own department, understanding the business processes one's department supports.
• Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Qualifications & Education
• Third Level science qualification (Microbiology is preferred).