Clinical Trial Supply Associate

6 days ago

Nottingham, United Kingdom Quotient Sciences Full time

**Company Overview**

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

**The Role**

Due to our continued growth and success, we have an excellent opportunity for a Clinical Trial Supply Associate to join our Global Clinical Trial Supply team within the Pharmaceutical Sciences Department. In this role you will be responsible for ensuring continuous supply of on-demand global clinical trial material for all ongoing studies and projects as directed by the Clinical Trial Supply Manager and/or Head of Global Clinical Trial Supply. This is based at our site in Nottingham.

You will be responsible for issuing Batch Manufacturing Records and clinical trial labels for scheduled manufactures and well as undertaking packaging operations in the GMP Cleanroom facility. You will also be involved with coordinating and booking shipments using Quotient approved couriers to ensure on time in full delivery of all Clinical Trial Supplies across the various Quotient production sites located in Nottingham, Reading and Philadelphia. You will also be responsible for tracking of all Clinical Trial Supply Shipments and ensuring full distribution documentation is in place at all times including final Proof of Delivery documentation.

**As a Clinical Trial Supply Associate, duties will include**:

- Issuing batch record and printing the subsequent labels required for the scheduled manufactures.
- Preparing for packaging manufactures by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling and weighing materials and supplies needed for the manufacture.
- Maintaining a safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures and monitoring the facility environment.
- Running shipping trials to check packaging for suitability and testing for performance under various conditions
- Assisting with BMR’s, label design, label translation, packaging labelling and configuration ideas.
- Producing shipping documentation and liaising with courier’s to book and track the scheduled shipments.
- Product returns and destruction coordination with sponsors.
- Ensuring adequate stock levels are maintained for Clinical Supply materials (Packaging, Excipient and Active Pharmaceutical Ingredient (API)) throughout the lifecycle of all pertinent studies.
- An understanding of GMP procedures and regulations
- A working knowledge of IWRS and labelling systems
- Excellent planning and communication skills and the ability to successfully organise and manage your time effectively
- Excellent attention to detail and working to tight deadlines.
- Excellent verbal and written communication skills
- Ability to build strong working relationships and to collaborate and influence colleagues and stakeholders

**Company benefits**

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.

**Our Commitment to Diversity & Inclusion**

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.

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