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QC Micro Analyst

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 19/06/2018
  • Job reference: J388250A

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QC Micro Analyst

Performs testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.

Responsibilities

  • Reviews and updates SOPs.
  • Performs peer review of data.
  • Performs laboratory investigation reports.
  • Participates in training of other employees.
  • Performs microbial identification procedures.
  • Maintains laboratory supplies, media, and reagents inventory.
  • Participates in the overtime and weekend schedule as required.
  • Performs bioburden and endotoxin testing of products and raw materials.
  • Performs microbiological testing of in-process and final product materials.
  • Performs biological and endotoxin indicator testing used in the validation of manufacturing equipment.
  • Updates microbiological environmental monitoring results database and prepares monthly report.
  • Performs acceptance testing of commercially prepared microbiological culture media.
  • Assists in coordinating equipment maintenance and calibration.
  • Uses Laboratory Information Management System (LIMS) for sample and sample test result tracking.
  • Performs all duties relevant to the Quality Control Microbiology Technician position as required.

Also desirable:

  • Increasing involvement in the training of employees.
  • Increasing responsibilities for reviewing documents and data.
  • Microbiology representation and participation in cross functional site meetings.
  • Administration of programs such as gowning, training, ordering, calibration, etc.
  • Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.

Education and Experience:

Requires BS/BA in Life Sciences or equivalent along with relative experience for levels beyond I (preferably in the pharmaceutical or biotechnology industries). Will substitute relevant work experience in lieu of degree requirement.

Please contact Kathryn on 016455250 or email for additional information on this and other potential positions.

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