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Barinthus Biotherapeutics

Quality Associate

Job Function:

Job Type:

Location:

Harwell

Based:

Closing date:

ABOUT THE ROLE

Key Responsibilities of the Role:

Working as part of the Quality team based in Harwell, UK, you will be responsible for:

  • Support the Senior Quality Assurance Manager in the management of the Barinthus Quality Management System.

  • Review Deviations, CAPAs, and Change Controls, providing guidance and support to ensure that problems are rectified, and recurrence prevented in accordance with regulations.

  • Review and approve batch related documentation, ensuring on-time completion to prevent any delays in supply for clinical trials.

  • Review and approve analytical documentation e.g. Out of Specification reports, analytical qualification plans/reports and stability protocols/reports.

  • Provide QA induction training for all new recruits.

  • Generate KPIs as requested by the Senior QA Manager.

  • Perform continuous improvement activities to ensure that we are working effectively, efficiently and compliantly as possible.

  • Identify potential compliance risks/gaps and recommend improvements.

  • Mentor and coach stakeholders in GxP, promoting a strong quality culture.

Additional Responsibilities of the Role:

  • Provide support during regulatory inspections, client audits & internal audits.

  • Perform internal audits and process audits when required.

  • Support the external (supplier) audit schedule and perform audits where appropriate.

  • Support Vendor Assurance activities (assessments of new and existing suppliers) including review of quality questionnaires as required.

  • Maintain and promote a state of inspection readiness at all times.

REQUIREMENTS

Qualifications and/or experience required to perform the role:

Essential

  • A degree in Life Sciences or equivalent experience.

  • Minimum of 3 years’ experience in a Quality role (Quality Assurance or Quality Control).

  • Knowledge of GxP standards/regulations e.g MHRA, FDA, ICH.

  • Good communication and interpersonal skills across an organisation working with global partners and with staff at all levels and from different cultures.

  • Excellent attention to detail when reviewing data, spelling and grammar and when comparing multiple documents to ensure that they all work cohesively.

  • Good problem-solving skills.

  • Ability to work independently and collaboratively to complete assignments within defined time constraints.

Desirable

  • Experience in Veeva Quality or other electronic quality/document management systems.

  • Experience in Veeva Clinical or other electronic trial master file systems.

  • Knowledge in GMP, GLP and GCP.

  • Experience working with CDMOs, CTOs and CROs.

  • Experience of conducting audits.

  • Experience of working with SmartSheets.

  • Good knowledge of Microsoft Office Applications (Word, Excel, PowerPoint, SharePoint, Teams, Outlook).

Barinthus Biotherapeutics' operates a hybrid working policy of 3 working days based in the Harwell office and 2 days working from home.

ABOUT THE COMPANY

At Barinthus Biotherapeutics, we’re always on the lookout for talented individuals who can contribute to our mission of advancing healthcare through innovative biotechnological solutions. If you don’t see a current opening that aligns with your skills and experience, we encourage you to send us a speculative CV at recruitment@barinthusbio.com. Please note that due to the high volume of CVs we receive, we may not be able to respond to every speculative application individually. Additionally, recruitment companies interested in partnering with us are advised to refer to the “Information for Recruitment Companies” section on our website for further guidance. We appreciate your interest in joining our team and look forward to potentially working together to drive progress in the biotech industry.


Barinthus Bio is an equal opportunity employer that is committed to diversity and inclusion in the workplace. As an employer, we are committed to ensuring representation of people from all backgrounds regardless of their gender identity or expression, sexual orientation, race, religion, ethnicity, age, neurodiversity, disability status, or any other aspect which makes them unique. We welcome applicants from all backgrounds to apply and would encourage you to let us know if there are steps, we can take to ensure that your recruitment process enables you to present yourself in a way that makes you comfortable.

HOW TO APPLY

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