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 deirdre.sheehan@collinsmcnicholas.ie 

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)

Comment

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Biopharma Report

Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More