Interim QA Associate - GMP/eQMS & Training Delivery

Cell and Gene Therapy Catapult

Stevenage

On-site

GBP 42,000 - 52,000

Full time

7 days ago
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Job summary

Cell and Gene Therapy Catapult in Stevenage seeks an Interim QA Associate to support the Pharmaceutical Quality System (PQS) across sites, maintain documentation, and assist with quality records and core competency training.

You will engage with the S-MIC Quality team to ensure right-first-time quality metrics, assist with inspection readiness and cross-site quality improvements at Stevenage and Braintree.

Qualifications

  • Experience working in a GMP or Quality Assurance environment.
  • Experience in the use and operation of an electronic QMS is advantageous.
  • Biologics or ATMP, or Sterile manufacturing is advantageous.

Responsibilities

  • Perform QA functions within the eQMS and GMP systems.
  • Issue, review, and reconcile controlled documents.
  • Maintain QMS trackers and generate trends for health monitoring.
  • Support with training content in QA functions for internal colleagues.
  • Support internal/external inspection preparation (e.g. MHRA).
  • Review quality documentation such as Non-Conformances, CAPAs, Change Controls, and procedure updates.
  • Support off-site archiving of logs, forms and reports.

Skills

GMP experience
QA mindset
Attention to detail
Communication skills
Team player
Travel flexibility

Tools

MasterControl
Ideagen

Job description

Cell and Gene Therapy Catapult in Stevenage seeks an Interim QA Associate to support the Pharmaceutical Quality System (PQS) across sites, maintain documentation, and assist with quality records and core competency training.

You will engage with the S-MIC Quality team to ensure right-first-time quality metrics, assist with inspection readiness and cross-site quality improvements at Stevenage and Braintree.

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