QC Microbiologist

Job Description

The Quality Control Scientist - Microbiology will ensure -that activities are conducted including Environmental monitoring / microbiology testing of starting materials, reagents, intermediate and finished products as required to support the site plan:

• Conduct laboratory analysis and result reporting to assure the QC service provision associated with viable environmental monitoring, starting material, raw material, excipient, in-process, and final product sample testing is maintained in line with therequirements of each Collaborator/external stakeholder.
• As required work with other QC personnel, QA, suppliers & service providers to assist in the development and maintenance of GMP compliant QC Laboratory services.
• Assist in the review and reporting of process trending charts for QC processes.

QC Sample Management & LIMS Management:

• Actively participate in the collection (from manufacturing modules and other classified areas), transportation, storage and lifecycle management of microbiological samples requiring testing either externally or to be performed within the CGT Catapult Braintreefacility.
• Support the microbiological testing of incoming materials, as required.
• Support the implementation and operation of a suitable electronic laboratory information management system (LIMS) for use in an appropriate timeframe and in accordance with the requirements of GMP.

Microbiology:

• Provide interpretation and guidance to the Site Leadership Team, and nominated Qualified Persons, as required.
• Coordination of workload to ensure the availability of results to meet site manufacturing and release schedule.
• Provision of expert advice to clients and other Collaborators/external stakeholders, as required.
• Conduct microbiology test validations and method qualifications.
• Provide support for process qualifications, such as aseptic gowning, good aseptic practises and media fills etc. as might be required.
• Participate in microbiological related training and qualification.

Regulatory Compliance:

• Support to ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards.
• Support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity).
• Generate and review cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc.
• Ensure archiving of both written and electronic data in accordance with company procedures.
• Support to ensure the CGT Catapult Braintree site team and associated service providers complete all documentation and records accurately, contemporaneously and to a consistent GMP standard.
• Support to ensure the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity.
• Participate in Out of Trend, Out of Specification and Deviation management events associated with QC activity and act as Collaborator/external stakeholder liaison to report and manage such events to an appropriate and compliant conclusion.