Quality Control Microbiologist

7 days ago

Dublin Pike, Ireland Guerbet Full time

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Overview We are looking for a Quality Control (QC) Microbiologist to join our team. In this role, the key areas of focus will be performing in process, water and finished product QC microbiology testing in the Microbiology Lab, managing environmental monitoring program and performing micro investigations. The ideal candidate will be goal driven, be able to provide support to the team, take initiative and drive change.
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 program
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 Education Requirements
Bachelors Degree in Microbiology.
Experience
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
Change control
Seniority level Associate
Employment type Full-time
Job function Manufacturing
Industries: Pharmaceutical Manufacturing
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