Quality Control (QC) Microbiologist

Guerbet; Dublin; Hybrid; EUR 40,000 - 60,000; Full time

Job summary

Guerbet, a global leader in medical imaging, is seeking an experienced Quality Control Microbiologist for our Dublin facility. The role covers in-process, water and finished product microbiology testing, environmental monitoring, and microbial investigations within a GMP lab.

The ideal candidate holds a Bachelor's in Microbiology with at least 3 years of GMP/pharmaceutical lab experience, knowledge of endotoxin and viable counts, and experience with LIMS is advantageous.

Qualifications

• Minimum 3 years relevant microbiology testing experience in a GMP/pharmaceutical setting, using hands-on analytical techniques.
• Experience with Contamination Control Strategy for API manufacturing plant with low bioburden / endotoxin limit.
• Cleanroom design and operation.
• LIMS experience advantageous.

Responsibilities

• Perform in-process, water and finished product QC microbiology testing in the Microbiology Lab.
• Manage environmental monitoring program and perform micro investigations.
• Conduct analytical validation of microbiological methods and introduce new techniques including method transfers.
• Train QC Chemists in microbiology methods and procedures.
• Support other QC tasks and drive continuous improvements.

Skills

Total Viable Count

Endotoxin Testing

Coliform Testing

Environmental Monitoring

Analytical Validation

Method Transfers

Staff Training

QC Troubleshooting

Education

Bachelor's degree in Microbiology

Tools

LIMS

Job description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go towww.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

We are looking for an experienced Quality Control Microbiologist to join our team at our Dublin facility. As part of the Quality Control team, the QC Microbiologist will be responsible forperforming in process, water and finished product QC microbiology testing in the Microbiology Lab, managing environmental monitoring program and performing micro investigations.

YOUR ROLE

General

• Responsible for API and Water testing with expertise in at least the following methods of analysis: Total Viable Count, Endotoxin Testing using Gel Clot and either Kinetic Chromogenic or Kinetic Turbidimetric methods, Coliform Testing
• Coordinate and perform environmental monitoring of packaging areas
• Investigate QC and API Manufacturing microbiology issues with support of QC Lead and Group Microbiologist
• Conduct analytical validation of microbiological methods
• Introduction of new techniques to the lab, including method transfers, validation protocols
• Train QC Chemists in appropriate microbiology test methods and procedures
• Other project work as determined by Quality Control Lead
• Support other QC tasks as required

Compliance

• Strict adherence to Aseptic techniques including sampling
• Strict adherence to GMP, including SOPs and Standard Works and where relevant, use of Pharmacopeial standards
• Key role in microbiology related risk assessments
• Adhere to the site safety programme
• Continuously improving the efficiency and performance of the QC Microbiology laboratory through:
• Implementation of modifications, improvements and work simplifications as appropriate
• Ensuring that investigations and root cause analysis are completed to drive improvements and determine root causes where required

YOUR BACKGROUND

• Bachelors Degree in Microbiology.
• Minimum 3 years relevant microbiology testing laboratory experience in a GMP/pharmaceutical setting, using hands-on analytical techniques
• Analytical Validation
• Experience with Contamination Control Strategy for API manufacturing plant with low bioburden / endotoxin limit
• Cleanroom design and operation
• LIMS experience advantageous
• Demonstrated lean capability advantageous