QC Microbiology Analyst

Orion Group Life Sciences are currently recruiting 2 x QC Microbiology Analysts on behalf of our Multinational Biopharmaceutical Client based in Swords, Dublin on an initial 11-Month contract with potential to extend (shift role).

Shift pattern is 4 days on & 4 days off, 7am to 7pm (Days).

Job Purpose:

The QC Microbiology Analyst role is a critically important activity to ensure efficient and effective compliant, 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 latest in analytical technics. The candidate will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry.

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 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.

Primary 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 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 Quality Management System requirements.
• Responsible for driving a culture of Continuous Improvement.

Qualification and Experience:

• 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.