QC Microbiology Analyst – Limerick | Collins McNicholas

QC Microbiology Analyst – Limerick

  • Reference: GY43631
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

As QC Microbiology Analyst you will perform a wide variety of microbial testing to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.

Responsibilities:

  • Reporting to the QC Laboratory Manager, the person will be responsible for the following;
  • Enters a Laboratory Cleanroom to collect and log samples for microbial analysis.
  • Performs bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs).
  • Performs or supports the sample analysis for microbial identification.
  • Performs environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
  • Performs acceptance testing of commercially prepared microbiological culture media.
  • Autoclaves microbiological media and laboratory waste as needed.
  • Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
  • Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
  • Assist in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments.
  • Participate in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program.
  • Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
  • Participates in the transfer of methodology from other test facilities.
  • Maintains laboratory reagents, media and supplies.
  • Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Initiates and completes CAPAs and Change Controls in accordance with site procedures.
  • Writes new and updates current SOPs as needed.
  • Provides training to other analysts in the QC group.
  • Presents analytical data reports clearly and concisely to management.
  • Proactively identifies and implements lab process improvements, lean initiatives.
  • Performs other duties relevant to the QC laboratory position as required.

Skills, Experience and Qualifications:

  • BS/BA in a scientific/technical discipline.
  • 1 – 2 years hands-on work experience in a regulated QC Microbiology laboratory within the biopharmaceutical industry.
  • Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage.
  • Excellent communication skills, both verbal & written.
  • Adaptable and flexible, willing to travel when needed.
  • Collaboration and team work. Maintains the highest standards of ethical behaviour.

For a confidential discussion and more information on the role/company please email your Cv to Amy: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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