QA Officer

OXB; Oxford; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in cell and gene therapy is seeking a QA Officer to support GMP analytical operations in Oxford. The role involves ensuring compliance with quality standards and collaborating with various stakeholders to maintain product quality and safety.

Benefits

Competitive total reward packages

Wellbeing programs

Career development opportunities

Supportive and collaborative culture

State-of-the-art lab facilities

Qualifications

• Experience in an ATMP / Biologics environment preferable.
• Excellent attention to detail required.
• Understanding of pharmaceutical industry QA requirements.

Responsibilities

• Oversee quality of GMP testing operations.
• Review quality systems documentation including Deviations and Change Controls.
• Perform inspections in GMP laboratory areas.

Skills

Attention to detail

Understanding of GMP

Education

A level or National Certificate in a Science discipline

Higher National Certificate or Degree in science discipline

Job description

Job description:

Join Us in Changing Lives

AtOXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful.

We are currently recruiting for a QA Officer to join the QA analytics team at Oxford Biomedica. The purposeof the role is to provide QA support to the Good Manufacturing Practice (GMP) analytical laboratory facilities.

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 ensuring quality compliance of analytical functions within the company. This includes but is not limited to; product testing operations, stability testing operations, method and equipment validations and ensuring compliance via the conduction of internal audits.

This is a PT9 grade role.

Your responsibilities in this role would be:

• Oversee quality of GMP testing operations to ensure adequate and timely release of GMP compliant product.

• Ensures that all documentation and quality records are reviewed and approved.

• Review quality systems documentation including Deviations, Change Controls and CAPA’s and to provide QA support to resolve compliance issues.

• Perform walk rounds/inspections in the GMP laboratory areas at appropriate and quality critical stages of the testing process to ensure the testing is performed to the GMP standards.

• To undertake continuous quality and process improvement for efficient way of working and to meet the current regulations.

• To liaise with stakeholders, e.g., laboratory/ production managers, internal customers to provide appropriate QA support and guidance to ensure compliance with GxP quality standard and any other regulations standards.

• To communicate updates on activities to the Management to ensure tasks are progressing and completed in timely manners.

Profile description:

We are looking for:

• 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 Us:

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. 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.

OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’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.

Why Join Us?

• Competitive total reward packages

• Wellbeing programmesthat support your mental and physical health

• Career development opportunitiesto 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

We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.

Ready to Make a Difference?

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.

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. 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 collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. 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.