Quality Assurance Officer (QA)

Oxford BioMedica Limited; Oxford; On-site; GBP 100,000 - 125,000; Full time

Job summary

A leading biopharmaceutical company in Oxford is seeking a QA Officer to support QA operations and analytics within GMP testing facilities. This role encompasses overseeing quality operations to ensure compliance with GMP standards and detailed documentation management. The ideal candidate should possess a science qualification and experience in the pharmaceuticals industry. The company offers competitive rewards, career development opportunities, and a collaborative culture.

Benefits

Competitive total reward packages

Wellbeing programmes

Career development opportunities

Supportive and inclusive culture

State-of-the-art labs and facilities

Qualifications

• A level or National Certificate in a Science discipline.
• Understanding of GMP and QA requirements in the pharmaceutical industry.
• Experience in an ATMP/Biologics environment is preferable.

Responsibilities

• Oversee GMP testing operations for timely batch release.
• Ensure documentation and quality records are approved post-batch completion.
• Review quality systems documentation including Deviations and Change Controls.
• Perform inspections in GMP manufacturing areas to ensure compliance.
• Oversee continuous quality and process improvements.
• Provide QA support and guidance to stakeholders.

Skills

Attention to detail

Understanding of GMP

Experience in ATMP/Biologics environment

Education

A level or National Certificate in a Science discipline

Higher National Certificate or Degree in science discipline

Job description

Overview

We are recruiting for a QA Officer to join either the QA Analytics or QA Operations team within QA. The role provides QA support for Oxford Biomedica's GMP Laboratory testing facilities or GMP Manufacturing facilities. The Quality Assurance (QA) team is responsible for the company's quality processes and systems, in compliance with GMP guidelines, and is accountable for internal and external audits, quality compliance and control.

Responsibilities

• Oversee quality of GMP testing operations or GMP manufacturing operations to ensure adequate and timely release of GMP compliant product.
• Ensure that all documentation and quality records are reviewed and approved on batch completion and forwarded to QP for on-time batch release.
• Review quality systems documentation including Deviations, Change Controls and CAPAs, and provide QA support to resolve compliance issues.
• Perform walk rounds/inspections in GMP manufacturing areas at appropriate and quality-critical stages of the testing process to ensure testing is performed to GMP standards.
• Undertake continuous quality and process improvement to enable efficient ways of working and to meet current regulations.
• Liaise with stakeholders (e.g., laboratory/production managers, internal customers) to provide appropriate QA support and guidance to ensure compliance with GxP quality standards and other regulations.
• Communicate updates on activities to Management to ensure tasks progress and are completed in a timely manner.

Qualifications

• A level or National Certificate in a Science discipline. Higher National Certificate or Degree in science discipline desirable.
• Understanding of GMP and pharmaceutical industry QA requirements.
• Excellent attention to detail.
• Experience of having worked in an ATMP/Biologics environment preferable.

About Oxford Biomedica

OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life-changing therapies to patients around the world. We are a company focused on responsible, responsive, resilient, and respectful values, and we collaborate with leading pharmaceutical and biotechnology companies in viral vector development and manufacturing (lentivirus, AAV, adenoviral vectors).

Why join us

• Competitive total reward packages
• Wellbeing programmes that support mental and physical health
• Career development opportunities to help you grow and thrive
• Supportive, inclusive, and collaborative culture
• State-of-the-art labs and manufacturing facilities
• A company that lives its values: Responsible, Responsive, Resilient, Respect