Interim QA Associate

Cell and Gene Therapy Catapult; Stevenage; On-site; GBP 32,000 - 46,000; Full time

Job summary

Cell and Gene Therapy Catapult in Stevenage is seeking a QA Associate to support the operation and performance measurement of the Pharmaceutical Quality System across CGT Catapult MICs in Stevenage and Braintree. You will maintain documentation, assist with quality records, and contribute to training in core QA competencies.

Ideal candidates will have experience in GMP or Quality Assurance environments, familiarity with electronic QMS systems, and a proactive, detail‑oriented approach.

Qualifications

• Experience in GMP or Quality Assurance environments.
• Familiarity with electronic QMS systems (MasterControl / Ideagen) is advantageous.
• Experience in Biologics, ATMP, or Sterile manufacturing is advantageous.

Responsibilities

• Perform QA functions within the eQMS (MasterControl / Ideagen) and other GMP computerised systems.
• Issue, review, and reconcile controlled documents with CGT Catapult departments and collaborators.
• Maintain QMS trackers and generate trends for monitoring health of the QMS.
• Engage with quality record owners to support right-first-time and on-time completion.
• Support inspection preparation with external regulators (e.g., MHRA).
• Review quality documentation such as Non-Conformances, CAPAs, Change Controls, and procedure updates.
• Assist with off-site archiving of departmental records and qualification projects.
• Write and deliver training content in QA functions for internal colleagues.
• Support GMP training delivery to internal and collaborator personnel.

Skills

GMP experience

QA experience

Communication

Teamwork

Detail-oriented

Willingness to travel

Tools

MasterControl

Ideagen

Job description

Description

The QA Associate will work within a team to support the operation and performance measurement of the Pharmaceutical Quality System (PQS) across CGT Catapult MICs (Stevenage and Braintree), maintain documentation in all forms, support assessment of quality records, and provide training to personnel in core competencies.

Application Deadline: 14 November 2026

Department: S-MIC Quality

Location: Stevenage (SMIC)

Description

The QA Associate will work within a team to support the operation and performance measurement of the Pharmaceutical Quality System (PQS) across CGT Catapult MICs (Stevenage and Braintree), maintain documentation in all forms, support assessment of quality records, and provide training to personnel in core competencies.

Key Responsibilities

• Perform QA functions within the eQMS (MasterControl / Ideagen) and other GMP computerised systems
• Issue, review, and reconcile controlled documents to CGT Catapult departments and Collaborator organisations
• Maintain QMS and Quality trackers and generate trends and graphs for effective monitoring of the health of the QMS by System Owners and Management
• Engage with quality record owners to support right-first-time and on-time completion.
• Support with Collaborator and external regulatory inspection preparation (e.g. MHRA)
• Review quality documentation such as Non-Conformances, CAPAs, Change Controls, Qualification records and procedure updates
• Support off-site archiving of departmental records (for example: logbooks, forms and reports) Support for computer system qualification projects as needed.
• Write and deliver training content in QA functions for internal colleagues
• Support the delivery of GMP training to internal colleagues and Collaborator personnel Provide support to activities across CGT Catapult MICs (Stevenage and Braintree) with periodic travel to the CGT Catapult Braintree facility Experience:
• Experience working in a GMP or Quality Assurance environment
• Experience in the use and operation of an electronic QMS is advantageous
• Experience in Biologics or ATMP, or Sterile manufacturing is advantageous.

Skills, Knowledge and Expertise

• Highly motivated, pragmatic, and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK
• High-level interpersonal, communication (oral and written) skills and emotional intelligence
• A good team player with a hands-on approach, and adaptable to new challenges
• Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs
• Flexibility towards work assignments and new learning
• Ambitious, collaborative, driven Accurate, with a strong attention to detail
• A positive attitude towards learning, personal and professional development
• Keeps up to date with industry best practice.
• Willingness to travel Ambitious, collaborative, driven
• Accurate, with a strong attention to detail
• Planning and time management of tasks to ensure deadlines are consistently met, factoring in the potential of changing circumstances
• Communicates with clarity and conciseness, understanding and adapting the message to engage different audiences
• Retains an engaged and active mind through routine processes/ procedures to remain alert to anomalies or situations requiring further thought/ action
• A positive attitude towards learning, personal and professional development.

CGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone’s contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. In 2024, we received bronze accreditation from Inclusive Employers.