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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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