Covance Lab Systems Coordinator in Harrogate, United Kingdom
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:
Performance management of all reportees incorporating:
Conducting PMD/objective setting and review meetings in a timely manner in accordance with company deadlines.
Use of third party feedback to monitor performance and set actions as appropriate
Conducting probationary review meetings for all new starters
Responsible for ensuring timely completion of:
Return to work/absence reviews
Instigation and management of individual improvement plans
Training file reviews
Resolution of day to day issues
Ensuring all personnel issues are dealt with in accordance with company P&Ps.
Ensure that the equipment procurement process is followed to maintain regulatory compliance
Preparation and maintenance of laboratory schedules with regards to non-study related activities (Equipment and Metrology, Quality Assurance, Internal Audits, Client Audits etc.)
Ensuring non-study specific operational quality defects and events are resolved with minimal disruption to study related work and scientific staff.
Work with GLS Process managers to identify general laboratory problems and seek to resolve and fix
In conjunction with QC Management, Scientists and Analysts, identify, coordinate and drive process improvement initiatives across BioPharmCMC with regards to activities such as streamlining, harmonisation, cost efficiencies etc.
Support recruitment activities in BioPhasrmCMC for entry level QC candidate.
General and Specific Analytical Skills and Techniques
Help support the development of training plans for new starters and assist or provide general laboratory training within the relevant group.
As required, provide appropriate training for BioPharmCMC staff to develop their skills and the group knowledge base, particularly with laboratory processes and maintenance.
Comprehensive understanding of routine use and maintenance of equipment appropriate to BioPharmCMC, including trouble shooting.
In depth knowledge of relevant data processing systems.
To help support equipment qualification within BioPharmCMC. This may include qualification design and protocol preparation.
Education / Qualifications
The post holder should ideally have a relevant degree and/or 3 to 5 years relevant industry experience.
The ability to get things done by influencing others (both internal and external).
Learn and maintain knowledge of process excellence, tools and activities.
The post holder should typically have:
Previous experience of direct line management is preferred, as the role will involve direct supervision of laboratory personnel on a daily basis.
Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
An understanding of health and safety policies, Company policies and procedures, and an understanding of GMP/GLP/GCP.
The post holder should be able to communicate effectively at all levels, with other Covance employees, as well as external clients, suppliers, etc.
Job Number 2018-19135
Job Category Scientific Advanced Degree
Position Type Full-Time
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