17993 – QC Microbiology Analyst – Dublin Contractor

Purpose

The QC Microbiology Analyst role is a critically important activity to ensure efficient and
effective compliant, qualification, and operation of the new strategic MSD 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 latest in
analytical technics. The candidate will work with a high performing cross functional team
of talent sourced from across MSD and the biotechnology industry. Together, the team
will build the future of MSD 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,
chemistry, bioassay, raw materials, stability, and in-process. Innovation and advanced
analytical methods (rapid ID technics, paperless lab, etc.) will allow the candidate
challenge current thinking in designing for the future. The candidate will have
responsibilities in the qualification of methods.

Responsibilities

• 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 with reference to pharmacopoeias,
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
• Possibility of shift work (24/7)

Requirements

• 1-3 years 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