UK ~ Nottingham
Clinical Supplies Associate
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
We have an excellent opportunity for a Clinical Supplies Associate. Working in Manufacturing Operations, you will be responsible for providing support and supplies coordination to the Manufacturing Operations group whilst maintaining a compliant GMP stores environment. You will need to prepare and coordinate supplies availability to support development and GMP activities, whilst working alongside colleagues in Pharmaceutical Operations and Quality Assurance.
- Arrange for procurement of development and clinical manufacturing supplies, drug substance, excipients, comparator products, final container closures and other supplies, in a timely manner. To inform CMC coordinator, PM, QC manager and other staff as appropriate where issues with timescales are identified.
- Undertake booking in, ensuring that all required paperwork necessary for booking in and release of supplies has been received or requested.
- In conjunction with study specific materials liaise with CMC Coordinators to ensure all study materials are available, sampled and released in a timely manner to meet the needs of the study. This may require assisting with sampling and co-operation with the QC group for material identification.
- Maintain appropriate overhead stock controls to ensure sufficient supply volumes are maintained at all times.
- Ensure compliant and accurate records of Clinical manufacturing materials are maintained and readily available for study specific monitoring visits.
- Undertake timely reconciliation and controlled disposal or client returns of development and clinical manufacturing supplies of drug substance, IMPS, excipients and comparator products as part of study close down activities.
- Co-ordinate shipping of materials and Investigational medicinal Products (IMPS) to clients or 3rd parties as applicable.
- Maintain a well organised, tidy and compliant GMP store in order to ensure adequate stock control and segregation.
- Work in a safe responsible manner at all times.
- Keep detailed and accurate records of work undertaken, ensuring records are clear, concise and legible at all times (as per GMP).
The ideal candidate will have previous procurement and administrative experience. Previous experience working in a GMP environment is desirable. You must be an organised individual, have a high attention to detail and should be able to work towards strict and tight project deadlines. The ability to juggle a range of tasks simultaneously and responding to client demands is also essential for this role.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.