Senior Quality Control Microbiologist Specialist

1 week ago

Tralee, Co Kerry, Ireland beBeeMicrobiologist Full time €55,000 - €85,000
Job Overview

This is a role that involves performing testing to ensure compliance with current Good Manufacturing Practices (cGMP) in the manufacturing facility.

Key Responsibilities:
  • Entering clean-rooms to collect and log samples for microbial analysis.
  • Performing bioburden and endotoxin sample analysis according to standard operating procedures.
  • Conducting sample analysis for microbial identification.
  • Performing environmental monitoring, including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
  • Verifying acceptance testing of commercially prepared microbiological culture media.
  • Autoclaving microbiological media and laboratory waste as required.
  • Ensuring all work is carried out in accordance with regulatory standards, company policies, and standard operating procedures.
  • Completing test records on time and peer reviewing data from other analysts for accuracy and completeness.
  • Assisting in the design and setup of the QC microbiology laboratory and selecting, implementing, and calibrating laboratory instruments.
  • Participating in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs.
  • Providing technical advice to manufacturing personnel in identifying microbiological root causes.
  • Participating in the transfer of methodologies from other test facilities.
  • Maintaining laboratory reagents, media, and supplies.
  • Investigating laboratory issues and generating reports in response to invalid assays, deviations, OOS/OOT.
  • Implementing corrective actions and change controls in adherence with site procedures.

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