20831-QC Micro Analyst-Dublin Contractor

This is an 11-month initial contract.

This is a shift working 4 days on & 4 days off, 7am to 7pm (Days), shift premium is 20% .

Purpose:

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 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 in analytical technics. The candidate will work with a high-performing cross-functional team of talent sourced from across the Site and the biotechnology industry. Together, the team will build the future of Company 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 analytical scope will incorporate micro, raw materials, stability, and in-process. Innovation and advanced analytical methods (rapid ID techniques, 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

Responsibilities:

• 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
• 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
• To integrate and complete all documentation on time and be familiar with LIMS
• Follow up-to-date analytical practices with reference to 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 programmes
• Participate and comply with the MSD Quality Management System requirements
• Responsible for driving a culture of Continuous Improvement

Requirements:

•  1-3 years of industry experience with significant knowledge and experience working in a Microbiology Laboratory

•  Experienced in testing as per the pharmacopeia’s

•  Working knowledge of QC Systems (eLogs, Electronic Lab Notebook, LIMS etc.)

•  Ability to respond to changing priorities

•  Strong organisational skills

•  Good verbal and written communication skills

•  Excellent troubleshooting and problem-solving skills

•  Good attention to detail

•  Ability to think logically and be proactive

•  Ability to work as part of a team and on own initiative in a constructive manner

•  Flexible and self-motivated