The Laboratory Systems Coordinator (LSC) is accountable for operational laboratory process and quality systems. The role requires significant interaction and coordination with operational and support functions (GLS/QA/Facilities etc.) in order to ensure the smooth and effective management of laboratory related activities and processes. A key responsibility of the LSC is the management of quality process improvement initiatives, as well as acting as a single point of contact for Equipment, Quality and Facilities (EQF), ensuring appropriate coordination and communication of EQF events with the laboratory groups.
The LSC is also accountable for on-boarding and associated training of new staff members. As such one of their day to day duties may include performance management of entry level QC Analysts, which includes planning and conducting general training relevant to that particular group. The LSC is expected to be aware of the various analytical methods performed within their area for the purpose of maintaining scientific knowledge and facilitates the training of new staff through coordination with the relevant QC Scientist and/or trainers. The LSC will coordinate with operational staff to ensure that new starters understand how the laboratory activities are managed and maintained, and that the processes and procedures that govern all laboratory activities are understood. .
The individual has a responsibility to work with the QC Management and Scientists (QC Scientists) to ensure compliance with applicable regulatory requirements (GLP/GCP/GMP) with regards to laboratory systems and processes, and act as a point of contact with Global Laboratory Systems and Quality Assurance for non-study related operational events and tasks. The LSC is also responsible for assisting or conducting laboratory tours as directed by QC Management in support of GMP audit inspections, and addresses regulatory or audit observations in order to rectify or prevent further occurrence of quality defects. The LSC also liaises directly with Equipment Management Associates to ensure minimal disruption to study work when equipment is undergoing routine maintenance or unexpected equipment breakdowns. Communication of events pertaining to laboratory events and resolution of any issues in an efficient manner is therefore a core component of this role.
As required, the post holder will be expected to provide appropriate procedural and technical training. The LSC is also required to work closely with QC laboratory group trainers to facilitate effective training, and assist with the maintenance or update of training materials. The LSC is able to get assistance from QC Scientists and Analysts for quality event resolution, but acts autonomously with regards to addressing general laboratory issues so that scientific staff are able to conduct study work with minimal disruption.
Reports to the Choose from list on a daily basis and provides regular group updates to ensure operational events are being communicated effectively.
The post holder will ensure adherence to the BioPharmCMC Laboratory SOPs and act as an operational and quality champion for laboratory processes and procedures.
The post holder will have direct responsibility for the following in relation to their direct reports:
The post holder should typically have: