OVERALL ROLE OBJECTIVE
The post holder will be responsible for analysis of materials and products and environmental monitoring samples to GMP standards, in addition they will assist in the implementation of quality assays into TC BioPharm’s Quality Control department. The post holder will work with and support the Quality Control, Quality Assurance, Facilities and Production team to ensure operational excellence and to exercise overall responsibility for QC Microbiology department.
The QC Microbiology Technician 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 Microbiology Supervisor. 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:
- Provide microbiological knowledge, practical expertise, problem solving/troubleshooting skills and good time management ability.
- Assist in environmental monitoring of the cleanroom facility
- Incubation and reading of environmental samples.
- Perform identification of any isolates using gram stain, catalyse, oxidase and identifications
- Perform sterility and endotoxin testing
- Assist in the control, receipt and release of raw materials, and final products to GMP requirements.
- Ensuring that analytical and microbiological equipment is calibrated and maintained in accordance with GMP quality systems. Be able to identify deviations and faults in instrument performance and report these to the microbiology supervisor/manager
- Report to the line manager, any deviations, environmental monitoring excursions or system suitability failure occurring during the manufacturing or quality control processes.
- Preparing and maintaining documentation to appropriate quality standards, including, but not limited to, laboratory notebooks, standard operating procedures, TSE evaluations, COSHH/BIOCOSHH assessments and Risk Assessments.
- Assist the line manager in microbiological laboratory activities including, but not limited stock control, ordering of reagents and consumables, ensuring equipment compliance and ensuring a clean, organised and smooth running working environment.
QUALIFICATIONS
- Degree level education in a sciences discipline.
SKILLS & EXPERIENCE
- Experience in microbiology techniques such as microbial identification.
- Experience in environmental monitoring of GMP cleanrooms.
- Excellent attention to detail with a desire to continually develop and improve our processes.
- The ability to work effectively within a small team.
- A determination to succeed.
- The ability to work under pressure.
- Flexibility and enthusiasm.
- Ability to work to deadlines and deliver results.
- Excellent written/oral communication and interpersonal skills
- Excellent Microsoft Office skills
- Thorough approach and high attention to detail
- Strong time management and organisational skills
Lab based.