Collins McNicholas

QC Microbiology Lead Analyst 

This role will involve performing tests to ensure cGMP compliance onsite.

You will also be responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.

 

Responsibilities:

  • Performs acceptance testing of commercially prepared microbiological culture media.
  • Support Product Testing and environmental monitoring sampling.
  • Administration of programs such as gowning, training, ordering, calibration, etc.
  • Microbiology representation and participation in cross functional site meetings.
  • You will be required to provide support to employees on the floor.
  • To ensure employees timesheets are completed on time.
  • To monitors employees training to ensure that all requirements are met, including OJT.
  • To maintain up to date training records for self and direct reports.
  • Perform monthly performance feedback meetings with direct reports.
  • Escalates all performance issues to management and/or HR.
  • Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
  • Assists in coordinating equipment maintenance and calibration.
  • Updates microbiological environmental monitoring results database and prepares monthly report.
  • Participates in the overtime and weekend schedule as required.
  • Participates in training of other new employees and prioritizes daily workload.
  • Performs peer review of data.
  • Performs laboratory investigation reports.
  • Maintains laboratory supplies, media, and reagents inventory.

Requirements:

  • Minimum BA/ BSc in Microbiology or related field.
  • 2+ years related experience in highly regulated lab working to cGMP regulations.
  • Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc.,
  • Collaboration and team work. Maintains the highest standards of ethical behaviour.
  • Results and performance driven.
  • Strong analytical ability and associated problem solving.

 

For more information or to apply for this position, please call Ben Forde on 061-512270

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