Quality Assurance Officer (12-18 Month Fixed-term Contract - Maternity Cover)

at  Owlstone Medical

Owlstone Medical’s mission is to change the way we currently diagnose and monitor serious disease; our vision is to become the global leader in the non-invasive detection of cancer, infectious disease, and inflammatory disease.
As we develop our technology and detection capability, we are continually evolving the requirements of our Quality Management System within the business.
We are looking for a QA Officer to join the QA team and support the business with the compliance of our QMS – Currently ISO9001:2015 and 21CFR Part 820, covering maternity leave for an estimated 12-18 months. The vision is also to certify to ISO13485 in 2025.

Key Tasks and Accountabilities

• Work with the Program/Project Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint
• Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes by way of conducting internal audits.
• Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule.
• Provide support with desk-based, remote and on-site audits of sub-contractors and suppliers.
• Working with other QA staff, provide support to departments, e.g. reporting on Quality Metrics as well as assisting in training of personnel on matters relating to the QMS and Induction of new starters on Quality aspects.
• Support Quality department initiatives as required, as part of a multi-disciplinary team

Working Arrangement: This is an onsite role based at our main offices on the Cambridge Science Park four days per week, with the ability to work from home one day per week, this day is a flexible day to meet the needs of the role and team.

SKILLS:

• Good inter-personal and communication skills
• Good organisational and time management skills

Education and Training

• Degree level qualification within Life Sciences (or equivalent)
• Trained and competent lead auditor (internal audits

Experience / Knowledge

• Suitable working knowledge within a Pharmaceutical/Medical Device QA department
• Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards
• Essential: ISO 9001, ISO 13485, GCP,
• Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits)
• Experience of an Electronic Document Management Syste

COMPETENCIES & REQUIREMENTS FOR THE ROLE:

Essential

• Planning and Organising
• Demonstrable evidence of the tasks outlined above
• Experience in writing quality procedures
• Strong presentation, communication and influencing skills
• Pragmatic with a flexible approach and the ability to deal with changing priorities
• Ability to work in a dynamic environment

Education and Training

• Degree level qualification within Life Sciences (or equivalent)
• Trained and competent lead auditor (internal audits)

Experience / Knowledge

• Suitable working knowledge within a Pharmaceutical/Medical Device QA department
• Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards
• Essential: ISO 9001, ISO 13485, GCP,
• Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits)
• Experience of an Electronic Document Management System

Key Tasks and Accountabilities

• Work with the Program/Project Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint
• Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes by way of conducting internal audits.
• Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule.
• Provide support with desk-based, remote and on-site audits of sub-contractors and suppliers.
• Working with other QA staff, provide support to departments, e.g. reporting on Quality Metrics as well as assisting in training of personnel on matters relating to the QMS and Induction of new starters on Quality aspects.
• Support Quality department initiatives as required, as part of a multi-disciplinary tea