Senior QC Technician- Microbiology

• To support the delivery of a GMP compliant manufacturing facility that optimises the regional benefit from the £30 million funding provided by NHSE.
• Support QC Microbiology validation activities for QC Equipment and processes under the MMC's MS Licence, ensuring the compliance with MHRA and NHS standards.
• Provides technical QC resource, advice, and support to ensure GMP compliance at the MMC.

• Perform routine Quality Control (QC) microbiology testing in accordance with approved Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP) and departmental procedures.
• Perform sterility testing on site in dedicated sterility testing isolator.
• Perform routine microbiological identification techniques, including the operation of equipment such as MALDI-TOF mass spectrometry, following appropriate training.
• Perform media growth promotion (fertility) testing, environmental monitoring, endotoxin testing, process biological/enzyme indicators and bioburden testing as required.
• Demonstrate and maintain appropriate cleanroom behaviours and aseptic techniques, including gowning, cleaning, transfer disinfection, environmental monitoring, documentation and adherence to GMP.
• Accurately record, review and maintain microbiology testing data in compliance with data integrity requirements and departmental procedures.
• Assist with microbiological investigations, including Out of Specification (OOS) results and deviations, providing factual information to support senior staff.
• Prepare, label, store and maintain microbiological reagents, media and consumables, ensuring appropriate stock control and rotation.
• Assist with the receipt, ordering and inventory management of QC microbiology materials and laboratory consumables.
• Support routine maintenance, calibration, qualification checks and servicing schedules for QC microbiology equipment, escalating issues where appropriate.
• Contribute to the preparation, review and updating of laboratory documentation, including SOPs, worksheets and logbooks under the guidance of senior staff.
• Assist in maintaining the cleanliness, organisation and compliance of the QC microbiology laboratories and associated cleanroom facilities.
• Support the training and induction of new members of staff and students in routine laboratory procedures where appropriate.
• Work collaboratively with colleagues across the Manufacturing, Quality Assurance and Quality Control teams to ensure the timely delivery of microbiology testing services.
• Comply with all Trust policies, Health and Safety requirements, GMP regulations and Quality Management System procedures.
• Demonstrate compassionate, inclusive and professional behaviours, contributing positively to team working, continuous improvement and a culture of quality and patient safety.
• To role model compassionate and inclusive leadership in order to shape the creation of a collective leadership culture within the trust. This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c) facilitates team working and collaboration within teams / departments and across organisational boundaries.

Desirable

• Experience working within a GMP-regulated pharmaceutical or aseptic manufacturing environment.
• Experience of environmental monitoring, sterility testing, microbial identification or media growth promotion testing.
• Experience using Pharmaceutical Quality Systems or Laboratory Information Management Systems (LIMS).
• Experience supporting equipment qualification, validation or routine maintenance activities.
• Knowledge of or experience in coaching and mentoring practices and tools.
• Knowledge of or experience in Quality improvement tools, techniques and methods.
• Experience participating in quality improvement activities.
• Experience training or mentoring colleagues in routine laboratory techniques.
• Experience using electronic quality management systems (eQMS).

Essential

• Relevant scientific qualification (e.g. BTEC Level 3, Foundation Degree, HNC/HND, Degree or equivalent knowledge and experience in Microbiology, Biomedical Science or a related discipline).

Desirable

• Degree in Microbiology or other relevant scientific discipline.
• Eligible to be Registered Professional with the General Pharmaceutical Council (GPhC), Health and Care Professions Council HCPC, Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB), or Royal Pharmaceutical Society (RPS).