The post-holder will be responsible for the day‐to‑day coordination and administration of key MTC activities, maintaining up‑to‑date communications with stakeholders, databases, the organisation and coordination of meetings. He/she will work closely with the MTC Service Manager and Production Manager in all matters of administration and operations and will be expected to provide an efficient and effective central point of contact and to facilitate the development and implementation of new business.
Responsibilities
* Coordinating donor recruitment process, from receiving the request to donor recruitment in the event of the absence or unavailability of the relevant personnel.
* Facilitating the coordination of FMT delivery to NHS sites in the event of the absence or unavailability of the relevant personnel.
* Maintaining MTC's donors and patient database in the event of the absence or unavailability of the relevant personnel.
* Being flexible with working hours (potential early start).
* Acting as the Quality Control releasing officer for Specials under training.
* Approval and monitoring of suppliers, goods receipt, designation and monitoring of storage areas/units for materials and products.
* Installation and validation of new equipment, maintenance, calibration and cleaning.
* Development and strict implementation of written procedures and documents forming part of the MTC quality management system, training of technical staff on new developments and contribution to internal/external audits and regulatory inspections, including corrective and preventative actions.
* Assisting the Quality Manager with the identification of assessment, root actions, non‑conformances, related to manufacture or quality control, risk cause analysis and implementation of corrective and preventative actions.
* Assisting the Quality Manager with the instigation and implementation of the appropriate procedures for controlling changes related to manufacture or quality control.
* Assisting the Quality Manager with trending of environmental monitoring data quarterly.
* Completion, maintenance and appropriate management of all the records, associated with the quality related duties carried out and ensuring the appropriate review and sign off.
* Assisting in the implementation of laboratory Health and Safety.
* Being willing to be trained in FMT production activities and being able to verify documents.
* Preparing Certificates of Analysis.
* Supports the University's sustainability agenda through resource efficient working.
* Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.
* Any other duties commensurate with the grade.
* Managing and overseeing the Centre budget and contributing to the setup and delivery of new services and clinical trials.
* Providing management support to the Centre Lead and Production Manager and interacting with internal and external stakeholders at various levels.
Qualifications
* A graduate with a good honours degree with experience in health care and/or the higher education sector.
* Proven relevant administrative skills with experience of coordinating and management support of scientific or clinical projects.
* Have deep understanding of the supply of unlicensed medicinal product ("Specials") MHRA guidance Note 14 2014, Human Medicine Regulations 2012 (SI 2012/1916), Regulation 167 of the human Medicinal Regulations 2012.
* Experience of GMP and pharmaceutical quality management system.
* Clear and articulate communication and high‑level interpersonal skills are an essential part of the role in order to establish the necessary key relationships with people and organisations both internally and externally and at all levels.
* Experience of external communications, particularly producing promotional material; web‑based and conventional.
* Excellent IT skills, particularly in spreadsheets and database management, and the ability to develop and implement sophisticated output and outcome monitoring and reporting systems.
* Good attention to detail and methodical approach to work with the ability to prioritise workloads in order to meet deadlines and have demonstrable problem‑solving skills.
* Excellent writing and minute‑taking skills.
* An ability to work proactively, with little supervision, under pressure and to deadlines.
* Ability to work on own initiative and to make decisions confidently whilst recognising their limitations with effective team working.
* Experience of working in a medical research environment and an understanding of scientific/medical terminology.
* A high degree of professionalism, tact, and diplomacy, and the ability to exercise discretion regarding the handling and management of sensitive information/issues.
* A high degree of initiative, personal judgement, resourcefulness, flexibility, and a self‑motivating approach.
* Ability to work effectively in a large, complex organisation, and to develop a good understanding of how the University and higher education institutions work.
* Knowledge of the protected characteristics of the Equality Act 2010, and how to actively ensure in day‑to‑day activity in own area that those with protected characteristics are treated equally and fairly.
Benefits
* 40 days paid holiday a year.
* One paid day a year for volunteering.
* Occupational sick pay.
* Pension scheme.
* Flexible working arrangements.
* Three high‑quality subsidised day nurseries.
* Resource efficient working and support for the university’s sustainability agenda.
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