Temp QC External Lab Coordinator
TEMP QC EXTERNAL LAB COORDINATOR (TRENDIN & DATA MONITORING) required by CareerWise Recruitment for our multinational BioTech client in the Mid-west (Ireland. The TEMP QC EXTERNAL 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. THE ROLE: * Support the implementation, expansion and continuous improvement of Application 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. REQUIREMENTS: * Requires a BSc/BA in statistics, mathematical sciences, biochemistry, chemistry or related field. * May consider another degree discipline with relevant experience; Experience in a biopharmaceutical setting is desirable. This job originally appeared on RecruitIreland.com.
78 days ago