QA Associate — GMP & QMS Documentation & Training

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

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.