QC Microbiology Analyst
3 weeks ago
An amazing opportunity has arisen for a QC Microbiology Analyst:
What you will do:
- 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 turbidmetric and MCS rapid endotoxin testing in compliance with GMP requirements.
- Integrate and complete all documentation on time and be familiar with LIMS.
- Train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, E.M testing, absence of bioburden testing and identification testing.
- Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
- Update SOP’s 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 / preventative 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.
What skills you will need:
- Science/Chemical Engineering/Biological Engineering.
- 1 - 5 years experience in the Pharmaceutical industry.
- Experience in performing Laboratory testing.
- Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
- Experience and critical skills in the area of expertise that add value to the business; ideally bioassay in a GMP setting.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Knowledge of cGMP & Laboratory Quality Systems.
As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
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