A growing global leader in the development, delivery and commercialisation of cell therapies have a fantastic job opening for a QC Specialist at their base in Hertfordshire. This is a dynamic and innovative organisation who pride themselves on their passion and expertise in the medical field.
- Performing testing of collaborator materials as well as company samples when required for biosafety e.g. detection of mycoplasma by PCR, detection of Endotoxin, detection of microbial contamination by direct inoculation, detection of microbial contamination by BacT/Alert etc.
- Completing the testing as per GMP requirements
- Reviewing data for accuracy before submission to Quality Control Specialist/QA
- Supporting the tactical execution of laboratory analysis and result reporting to assure the QC service provision associated with environmental monitoring in Grade B to D areas, starting material, raw material, excipient, in-process and final product sample testing using microbiology techniques, microbial identification endotoxin testing, Sterility Testing, mycoplasma testing by PCR, Cell count and viability testing, microscopy etc, is maintained in line with the requirements of each collaborator.
- Performing Trend analysis of data and participate in periodic reviews of the services.
As required work with QC personnel, QA, suppliers & service providers to assist in the development and maintenance of GMP compliant QC Laboratory services.
- Supporting the Sample Management function to ensure the QC group provides a timely, effective and efficient service for the collection (from manufacturing modules and other classified areas), transportation, storage and lifecycle management of collaborator and company derived microbiology and environmental monitoring samples
- Supporting collaborator raw material sampling activity and ensuring it is undertaken to GMP and in accordance with collaborator requirements.
- Providing support for aseptic process qualifications, such as aseptic gowning, good aseptic practices and media fills etc.
- Supporting microbiological Out of Specification investigations.
- Supporting other testing needs as identified from time to time by collaborative agreements.
- Supporting to ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards.
- Supporting to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity).
- Supporting to ensure the team and associated service providers complete all documentation and records accurately, contemporaneously and to a consistent GMP standard.
- Supporting to ensure the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity.
- Participating in Out of Trend, Out of Specification and Deviation management events associated with QC activity and assisting in the reporting and management of such events to an appropriate and compliant conclusion.
Skills and Requirements:
- Bachelor's degree in Microbiology, Biotechnology, or related discipline.
- Experience working in aseptic (bio) pharmaceutical manufacturing environment and QC laboratory operating according to GMP using techniques described, for a minimum of 2 years.
- Experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements.
- Highly motivated, pragmatic and practical to support the mission of the company to assist in the acceleration of the development of a commercial side of the business industry in the UK.
- Project ownership and pride in its delivery.
- Passion for delivering excellent customer service.
- Flexibility towards work assignments and new learning.
- Ability to manage multiple and varied tasks and prioritise workload with attention to detail.
- Comfortable operating autonomously once goals and objectives are set.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Maddalena Sarnataro at 0203 854 2625 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.