OVERALL ROLE OBJECTIVE
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. In addition, they will manage QC testing and reference samples, perform visual inspections of TC BioPharm’s clinical products as well as shipping of product to clinical sites. The post holder will work with and support the Production, Supply Chain, Quality Control and Quality Assurance teams to ensure operational excellence and to exercise overall responsibility for compliance to GMP procedures in all areas.
The QC Material and Sample Management Senior Coordinator will join TC BioPharm Ltd (TCB), an established cancer immunotherapy company developing cell based treatments for cancer and severe viral infections. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the QC Material and Sample Management Senior Coordinator. TCB is a fast growing, immunotherapy company developing cell-based treatments for cancer patients; moreover, our unique culture, values and working environment attracts, retains, and inspires people to give their best.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Perform visual inspections of final product.
- Responsible for liaising with third-party suppliers, clinical trial sites and Supply Chain department to arrange sample and product shipments.
- Banking of cell aliquots and final product using controlled rate freezers. Whilst ensuring stock control and maintenance of liquid nitrogen tanks.
- Perform investigations in compliance with the Quality Management System.
- Prepare and maintain documentation to appropriate quality standards. Examples of these may include; standard operating procedures (SOPs), material and product specifications, change controls and risk assessments.
- 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.
- Maintenance of stock levels and stock rotation, enforcing adherence to a FEFO system.
- Training and supervising both experienced and inexperienced members of staff so that technical knowledge and competence is communicated effectively. Where applicable, correct and coach colleagues to ensure continuance of a high level of expertise.
- Lead improvement projects to ensure regulatory compliance and streamlining of processes.
- Ensuring work is performed in accordance with the Company’s QA and Health and Safety policies including the provision of COSHH/BIOCOSHH/Risk assessments.
- Maintenance of training records prior to undertaking specific duties.
- Assisting the line manager/supervisor in management activities including, but not limited to equipment planning/procurement, ordering of reagents and consumables, maintaining calibration and servicing records, ensuring equipment compliance and ensuring a clean, organised and smooth-running working environment.
QUALIFICATIONS
- Degree level education in a sciences discipline.
SKILLS & EXPERIENCE
- At least 2 years’ experience within an GMP manufacturing facility
- Experience in management of QC testing and Final Product samples is desirable.
- Experience working in material handling within a GMP environment is essential
- Experience in working with a quality management system and relevant GMP documentation is essential.
- Experience in material inspections, checking certificates, TSE statements, specifications is desirable
- 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 written/oral communication and interpersonal skills
- Excellent Microsoft Office skills
- Thorough approach and high attention to detail
- Strong time management and organisational 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 on a truly global scale.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.
Full-time, permanent role, working 37.5 hours per week Monday to Friday - some ad hoc irregular working hours may be required.
Laboratory/Stores based.