Operations Associate

Role Overview

We are currently looking for a Operations Associate to join a leading Cell and Gene Therapy company based in the Hertfordshire area. As the Operations Associate you will be responsible for supporting the manufacture and release of products under the Quality Management System environment, supporting product and batch record reviews, investigations into non-compliances, CAPA management, supplier qualification and documentation controls.

Key Duties and Responsibilities

Your duties as the Operations Associate will be varied however the key duties and responsibilities are as follows:

1. As the Operations Associate, you will compose SOPs and other documentation to support and control supply chain and inventory activities.

2. You will undertake administrative duties, checking delivery documentation and be the first point of contact for inbound related queries, as well as acting as the interface between suppliers and third parties.

3. In your role as the Operations Associate, you will be responsible for supporting supply chain deviations, investigations, incidents and CAPAs as required.

4. As the Operations Associate, you will support the development and continuous improvement of ERP inventory management software.

Role Requirements

To be successful in your application to this exciting opportunity as the Operations Associate we are looking to identify the following on your profile and past history:

1. Relevant degree in a a related scientific field.

2. Proven industry experience in a GMP environment in a biotech or biologics based company.

3. A working knowledge and practical experience with FDA / MHRA / EU / ICH standards.


Key Words: CAPA / SOP / GMP / Supply Chain / QMS / Quality Management System / Documentation / Warehouse / Supplier management / Deviations