Quality Control Microbiologist

Guerbet; Leinster; On-site; EUR 36,000 - 60,000; Full time

Job summary

Guerbet in Ireland seeks a QC Microbiology Specialist to perform in-process, water and finished product microbiology testing in the Microbiology Lab, manage environmental monitoring, and contribute to micro investigations. You will prepare media, run Growth Promotion tests, and support investigations with the QC Lead.

Requirements include a Bachelor's in Microbiology and 1–3 years' GMP/pharma lab experience, with endotoxin/microbial testing and LIMS experience preferred.

Qualifications

• Bachelor's degree in Microbiology.
• 1–3 years of GMP/pharma microbiology lab experience.
• Analytical validation of microbiological methods.
• Experience with contamination control in API manufacturing is advantageous.
• Lean capability is advantageous.

Responsibilities

• Perform in-process, water and finished product QC microbiology testing in the Microbiology Lab.
• Coordinate and perform environmental monitoring of packaging areas.
• Prepare media and perform Growth Promotion Test.
• Conduct bioburden testing of API, water and other samples.
• Support OOS, deviation, CAPA and microbiology investigations with QC Lead.
• Maintain ALCOA+ compliant laboratory documentation.
• Carry out analytical validation and introduce new lab techniques.
• Train QC Chemists in microbiology methods and procedures.

Skills

Total Viable Count

Endotoxin Testing

Environmental monitoring

Growth Promotion Test

Bioburden testing

GMP compliance

ALCOA+

Analytical validation

Method transfers

LIMS experience

Lean capability

Education

Bachelor's Degree in Microbiology

Tools

LIMS

Job description

Role Purpose: This position reports into the Quality Control (QC) Lead. The key areas of focus is performing in process, water and finished product QC microbiology testing in the Microbiology Lab, managing environmental monitoring program and performing micro investigations.

• 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.
• Coordinate and perform environmental monitoring of packaging areas.
• Prepare microbiological media and perform Growth Promotion Test.
• Perform bioburden testing of API, water and other applicable samples.
• Support OOS, deviation, CAPA and microbiological investigations related to QC and API Manufacturing, with support of QC Lead and Group Microbiologist.
• Maintain accurate laboratory documentation in compliance with GMP and ALCOA+ principles.
• 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

Education Requirements

• Bachelors Degree in Microbiology.

Experience

• Minimum 1-3 years relevant microbiology testing laboratory experience in a GMP/pharmaceutical setting, using hands-on analytical techniques
• Analytical Validation of microbiological methods
• 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