Owlstone Medical: Document Controller / QA Assistant


Owlstone Medical’s mission is to save 100,000 lives and save health care providers $1.5B. With several major projects underway to develop disease screening and diagnosis based on detection of metabolic products in breath, we are looking for an experienced instrument operator to join our clinical laboratory team based in Cambridge, UK.

The Purpose of the Post:

This role will support the Quality Assurance team to ensure that the company meets the requirements of ISO 9001:2015, ISO 13485:2016 and 21 CFR part 820. The post holder will carry out vital administration tasks that ensure that the QA department meets key objectives and maintains ISO accreditations.

 

Key Responsibilities and Duties:

  • Assist with the management of controlled QMS documents including assignment of document numbers, upkeep of logs, scanning documents and filing documents in physical and digital records ensuring all staff have access to necessary documentation
  • Administration activities with relation to tracking tasks, monitoring and reviewing the status of actions
  • Assist with document creation and update where necessary
  • Provide proof-reading skills when required
  • Support the QA department to maintain and meet regulatory requirements and maintain ISO accreditations
  • Distribute project-related copies of documentation to internal teams

 

INDIVIDUAL SPECIFICATION

Essential Experience and skills

  • 2-5 years’ experience of document control, ideally in a manufacturing environment
  • Excellent IT skills (MS Office)
  • Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
  • Self-starter with strong motivational skills
  • Good written skills, demonstrated in a range of contexts
  • Effective communication and inter-personal skills
  • The ability to work with critical attention to detail and high levels of accuracy
  • Experience in working for a small, dynamic organisation
  • Experience of following Good Documentation Practice

 

Desirable Experience and skills

  • Experience of working in a ISO 13485 accredited environment
  • Experience of using an Electronic Document Management System (EDMS) such as Q-Pulse or CogniDox

 

About Owlstone:

Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com.

Every time you breathe out there are hundreds of chemicals on your breath – some are tell-tale markers of disease that our microchip chemical sensor technology is able to detect.

Our vision is to change the way we currently diagnose and monitor serious disease; we aim to become the global leader in the non-invasive detection of cancer, infectious disease and inflammatory disease. The key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage drop to about 5% – unfortunately there are still far too many people detected at late stage.

The Owlstone group also commercialises a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defence.

We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on people’s lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone may be the place for you.

To apply, please submit your CV and a covering letter explaining why you want to work with us and how you fit the role to email.