Document Controller

Job description:

We want you to feel inspired every day. We’re future-focused and our business is growing. We succeed together through passion, commitment and teamwork, and so can you.

We are currently recruiting for a Document Controller to join the Quality Assurance team. The purpose of this role is to provide GxP documentation to support manufacturing, research and validation activities whilst ensuring maintenance of Document Control systems across the business.

Oxford Biomedica’s Quality Assurance (QA) team is responsible for the company’s quality processes and systems, in compliance with GMP guidelines. The team are accountable for internal and external audits, quality compliance and control.

Your responsibilities in this role would be:

• Provide working copies and controlled copies of paper documents such as batch records, logbooks and labels for numerous company functions such as the Manufacturing department.
• Maintenance of current documentation in the electronic document management system and paper based filing system.
• Provide administration support for the electronic document management system and troubleshooting for document writing.
• Preparation of documentation for the offsite archive and recall documents upon request.
• Maintenance of stationery stock.
• Participate in continuous improvement initiatives to enhance working practices.
• QA Administrative departmental support.

Profile description:

We are looking for:

• A level of English and Mathematics and ideally Science preferably to A Level.
• Proficient in Microsoft Office Word, Excel, Outlook and Powerpoint
• An understanding and GMP or GXP and pharmaceutical industry QA / Documentation is preferred.
• The ability to prioritise daily workload in order to meet deadlines.
• Able to work on own initiative.
• Demonstrate a good attention to detail.

About Us:

Oxford Biomedica is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.

These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

What’s in it for you:

• Highly total reward packages
• Wellbeing programmes
• Development opportunities
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• Our values are: Deliver Innovation, Be Inspiring and Have Integrity
• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

Collaborate. Contribute. Change lives

We offer:

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.

This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).

Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.