Collins McNicholas

External QC Lab Coordinator.


This External QC Lab Coordinator will provide data and statistical trending support, to establish, organise and maintain effective data co-ordination and data trending monitoring of release and reference standard data for biological drugs.

Job Description:

  • Support the implementation, expansion and continuous improvement of the release and reference standard trending program.
  • Accurately source process data from paper database systems (i.e. LIMS) to support release and reference standard monitoring needs.
  • Perform data co-ordination and verified data entry tasks.
  • Use statistical process control and process capability to monitor process performance and identify trends.
  • Work with cross-functional departments to co-ordinate data collation.
  • Issue knowledge base reports summarising conclusion of data reviews and trending.
  • Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
  • Review and approve method transfer validation protocols and reports.
  • Assist the external laboratories in troubleshooting and identifying root cause analysis and provide technical advice as needed.
  • Initiates and completes CAPAs and Change Controls in accordance with site procedures.
  • Performs other duties relevant to the position as required.

Job Requirements: 

  • BA in statistics, mathematical sciences, biochemistry, chemistry or related field.
  • Experience in a biopharmaceutical/pharmaceutical environment.
  • Excellent Communication skills, both verbal & written.
  • Collaboration and team work. Maintains the highest standards of ethical behaviour.
  • Strong analytical ability and associated problem solving.
  • Good time management and attention to detail.

For more information or a confidential discussion contact Deirdre Sheehan on 061-512270 or 

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