QC Microbiology Analyst-Shift

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. To maximize the development opportunity, the candidate will be the key talent in analytical Microbiology techniques and in current Pharmacopeial methods. The facility will utilize the latest innovations in technology and automation. 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 candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role. The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise. The full analytical scope of QC will incorporate microbiology, mycoplasma (DNA) analytics, analytical 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 an 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 role functions include:

• 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 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, 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 SOPs 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 / preventive 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, 7-7 days only. 4 on 4 off.

• 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.
• 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 oriented manner.

• Third Level science qualification (Microbiology is preferred).