This role is an 11 Month Contract with a view to extension.
This is a shift working 4 on & 4 off. Days and Nights. We will start on Days/afternoons (2 cycle at 20% shift allowance), and then will move to 24/7 (4 cycle at 33.33%) – Flexibility for all shifts is required here.
The QC Microbiology Analyst role is a critically important activity to ensure efficient and effective compliance, qualification, and operation of the new strategic Drug Substance facility. This tremendous opportunity will be responsible for qualifying for 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 facility will utilize the latest innovations in technology and automation and the latest analytical technics. The candidate will work with a high-performing cross-functional performing cross-functional team of talent sourced from across the biotechnology industry. Together, the team will build the future of The Company’s biologics through A quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team. The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise. The full QC’s 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 to challenge current thinking in designing for the future. The candidate will have responsibilities in the qualification of methods.
• The motivation to be an inspiring member of a high-performing team.
• The desire to continuously learn, improve and develop.
• Perform supportive activities for general lab readiness, laboratory equipment
qualification and method qualifications.
• 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 concerning pharmacopeias, 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.
• 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 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 programs.
• Participate and comply with The Company’s Quality Management System requirements.
• Responsible for driving a culture of Continuous Improvement.
• Possibility of shift work (24/7).
• 1-3 years of industry experience with significant knowledge and experience working in a Microbiology Laboratory.
• Experienced in testing as per the pharmacopeias.
• Working knowledge of QC Systems (eLogs, Electronic Lab Notebook, LIMS, etc.)
This role is an 11 Month contract with a view to extension. Purpose The Quality Associate Specialist/ Specialist will provide...Apply For This Job
This is a 12-month contract. This position is on a 24/7 rotation which consists of days and nights. Please note...Apply For This Job
Purpose This is a 10 month contract This position is responsible for actively identifying opportunities for process and compliance improvement...Apply For This Job
Purpose As a Reliability Engineer, you will provide Technical support to the Production Department on reliability improvement elements, as directed...Apply For This Job
This is a 12- month contract with our pharma client in Dublin. Purpose: This role requires a minimum of 3...Apply For This Job