Senior QA Technician - Cell and Gene Therapy Service in London

An excellent opportunity has presented itself at Great Ormond Street Hospital Trust, Zayed Centre for Research into Rare Disease in Children (ZCR) for a Senior Quality Assurance Technician in our Cell and Gene Therapy Service. We are proud of being part of a well renowned national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK.

The Cell and Gene Therapy Service manufactures life-saving therapies for paediatric patients under both our MHRA and HTA licences. We are expecting to soon manufacture within our new state of the art, purpose-built facility (ZCR), comprising of seven cGMP compliant laboratories and support services. Our manufacturing facilities are licensed by the MHRA to allow us to function within the terms of our MIA(IMP) and MS licences.

This is a fantastic opportunity to join our friendly and welcoming Quality team with its great diversity of skills and experience, we look forward to receiving your application.

Main duties of the job:

• The Senior Quality Assurance Technician will play a vital role in the maintenance of our Quality Management System (QMS).
• The postholder will be responsible for managing and reviewing deviations, change controls, quality risk assessments, corrective and preventative actions (CAPAs), and other quality records.
• Additionally, the postholder will also conduct investigations, root cause analysis, supplier assessment and approval activities and support with the review of batch manufacturing records and clinical trial / specials batch related documentation.
• The postholder as a member of the Quality Assurance team will work closely with the Production teams to build quality into the department, support staff in their training needs and ensure work is carried out in accordance with local, national and professional standards and regulatory guidelines.

We are therefore seeking a candidate with a strong background in quality management systems and a comprehensive understanding of GMP principles. The ideal candidate should demonstrate excellent organisational skills, attention to detail, and problem-solving abilities. Effective communication, both written and verbal, is crucial for collaborating with internal teams and external partners. Previous experience working in a QA / GMP environment and familiarity with gene, stem, and cellular therapies are highly desirable qualities for this role.

GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role; through a process that is fair, open, consistent and free from bias and discrimination. We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged. All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed. We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members.

We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion. We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women’s staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust’s mission, values and efforts specific to inclusion. All of our staff networks are open to any employee.

Detailed job description and main responsibilities:

The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required.

Essential criteria:

• Educated to degree level in relevant scientific discipline
• Training in QMS, QA or relevant experience
• Understanding of GMP principles
• Experience of working in a QA environment
• IT competent (Word, Excel and Power Point)
• Good organisational skills (ability to plan, organise and prioritise work)
• Good problem-solving skills
• Good attention to detail and accuracy
• Strong communication skills (verbal and written)
• Ability to accurately follow written and oral instructions
• Ability to work independently and as part of a team
• Show initiative and provide support to staff inexperienced in quality systems