23152-QC Micro Analyst-Dublin Contractor

Purpose

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.

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 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.

Qualifications

• Third Level science qualification (Microbiology is preferred).
• 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.

This is an 11 month initial contract and is a shift position. The shift is extended days – 4 days on 4 days off 7am -7 pm.