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.
- 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.
- 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 email@example.com