Advanced Therapy Quality Assurance Assistant

The Methodist Church in Britain; Royal Borough of Greenwich; On-site; GBP 42,000 - 62,000; Full time

Job summary

Guy's Hospital Advanced Therapy GMP Unit seeks a QA professional with GMP experience to support its quality system and grow into an ATMP QA specialist. This role covers deviations, change control, environmental monitoring data, batch records and routine QA queries from core staff and collaborators.

Two years in quality assurance and an immunology, haematology or equivalent background are essential. The post sits with the Clinical Research Facility and offers opportunities to advance in ATMP

Qualifications

• Two years' experience working in quality assurance.
• Expert knowledge and hands‑on experience of GMP or equivalent.
• Experience with process qualification and equipment validation for GMP.
• Some experience using an electronic pharmaceutical quality system.
• Some experience providing training.

Responsibilities

• Review planned deviations for impact and risk before implementation, and report deviations to line managers.
• Raise preventive actions and change controls, and implement audit and inspection findings.
• Assist in managing and monitoring QA and QC activities, and prepare quality data for ATMP certification.
• Make strategic judgements within PQS boundaries on technical failures, PPM, QC assessments, material suitability and anomalous results.
• Contribute to internal and collaborator quality meetings, tracking open deviations and reporting KPIs.
• Support the operation of the electronic PQS, help design and qualify a new ePQS, and keep logs current.
• Escalate overdue PQS items to appropriate personnel, including the Heads of unit.
• Handle day-to-day QA queries from core staff and collaborators, and assist with supplier and raw material approval.
• Ensure collaborators using the cleanrooms follow procedures and train new users in basic GMP.
• Lead collation, trending and escalation of environmental monitoring data and micro exceptions, and ensure timely micro deviation investigations.
• Collate batch manufacturing records ready for head of unit and QP review.
• Distribute master SOPs to GMP areas, audit them regularly, review engineer reports and log non-conformances.

Skills

Independent work

Team collaboration

Communication skills

Education

BSc Immunology/Haematology or equivalent

Job description

The Advanced Therapy GMP Unit at Guy's Hospital makes cell and gene therapy products for early-phase trials, and this quality assurance post supports its quality system. The work covers deviations, change control, environmental monitoring data, batch records and routine QA queries from core staff and collaborators. It sits alongside the Clinical Research Facility and suits a QA professional with GMP experience who will grow into an ATMP QA specialist. Two years in quality assurance and an immunology, haematology or equivalent background are essential.

What the job involves

• Review planned deviations for impact and risk before implementation, and report deviations to line managers
• Raise preventive actions and change controls, and implement audit and inspection findings
• Assist in managing and monitoring QA and QC activities, and prepare quality data for ATMP certification
• Make strategic judgements within PQS boundaries on technical failures, PPM, QC assessments, material suitability and anomalous results
• Contribute to internal and collaborator quality meetings, tracking open deviations and reporting KPIs
• Support the operation of the electronic PQS, help design and qualify a new ePQS, and keep logs current
• Escalate overdue PQS items to appropriate personnel, including the Heads of unit
• Handle day-to-day QA queries from core staff and collaborators, and assist with supplier and raw material approval
• Ensure collaborators using the cleanrooms follow procedures and train new users in basic GMP
• Lead collation, trending and escalation of environmental monitoring data and micro exceptions, and ensure timely micro deviation investigations
• Collate batch manufacturing records ready for head of unit and QP review
• Distribute master SOPs to GMP areas, audit them regularly, review engineer reports and log non-conformances

Qualifications

• BSc in Immunology, Haematology or equivalent experience

Experience

• Two years' experience working in quality assurance
• Expert knowledge and hands‑on experience of GMP or equivalent
• Experience with process qualification and equipment validation for GMP
• Some experience using an electronic pharmaceutical quality system
• Some experience providing training

Skills & knowledge

• Ability to work independently
• Ability to work collaboratively and as part of a team
• Ability to communicate complex ideas verbally and in writing

Nice to have

• PhD and/or MSc in Immunology, Haematology or equivalent
• Specialist knowledge of somatic cell and gene therapy manufacture within GMP
• Experience in cellular immunology techniques and analyses: proliferation, characterisation and safety tests
• Specialist knowledge of environmental monitoring, GMP cleanroom cleaning, and maintenance and qualification of specialist equipment
• Specialist knowledge of deviation management within a pharmaceutical quality system
• Experience training staff and students
• Some experience of ATMP manufacturing