The post holder will work within the Quality Control department to assist in the handling of raw materials, and take lead in material documentation and process improvements. They will ensure operational excellence and compliance to GMP procedures in all areas.
OVERALL ROLE OJBECTIVE
The QC Material and Sample Management Coordinator will support the QC Stores function at TC BioPharm Ltd (TCB), an established, fast-growing immunotherapy company developing future cancer and infectious disease treatments. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the Quality Control Materials Supervisor.
Responsibilities include but are not limited to:
- Independently work to control raw materials, and intermediate manufacturing components, to ensure material, product, and patient quality is not compromised.
- Regularly perform material inspections to prevent the introduction of product contaminants into the manufacturing process.
- Liaise with suppliers to ensure required material documentation is available in a timely manner.
- Preparation of Bill of Materials (BoMs) for GMP manufacturing.
- Maintenance of stock levels and stock rotation, enforcing adherence to a FEFO system.
- Support TCB’s biobanking program through stock management, organisation of testing, and compilation of testing results.
- Responsible for liaising with third-party suppliers to arrange sample and product shipments.
- Work in accordance with TCB’s QA and Health and Safety policies including the provision of COSHH/BIOCOSHH/Risk assessments.
- Lead improvement projects to ensure regulatory compliance and streamlining of processes.
- Prepare and maintain documentation to appropriate quality standards. Examples of these may include; standard operating procedures (SOPs), material and product specifications, TSE evaluations, COSHH/BIOCOSHH assessments and risk assessments.
- Maintain the laboratory areas through cleaning and general housekeeping. General housekeeping responsibilities may include; submission of purchase orders, and tracking of equipment compliance; while maintaining a clean and organised working environment.
- Perform investigations to in compliance with the Quality Management System.
- Maintenance of training records prior to undertaking specific duties.
Qualifications:
- HND or HNC in a Biological discipline.
Essential skills & experience:
- Previous experience working in material handling within a GMP environment is desirable.
- Experience in material inspections, checking certificates, TSE statements, specifications and preparation of associated GMP documentation.
- Completing and updating GMP documentation including SOPs, material specifications and TSE evaluations, and risk assessments.
- Experience in performing and reporting deviation investigations using root cause analysis techniques.
- Experience in stock management and preparing BoMs for manufacture.
- Experience in using Microsoft office packages.
- Excellent attention to detail with a desire to continually develop and improve processes.
- Flexibility, passion and enthusiasm to support the company out of office hours as required.
- Excellent communication and interpersonal skills to maintain professional relationships with internal and external stakeholders.
- Exceptional organisational and time management skills.
If you are looking to work within a challenging, dynamic and rewarding environment, then TCB represents an excellent career move. This is an opportunity to be part of a growing, ambitious business where people development is critical to future success. As we continue to expand, there will be career opportunities.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary, reviewed annually, we offer a comprehensive range of benefits and an excellent working environment.