GMP Quality Assurance Associate

7266-Janssen Biologics B.V. Legal Entity

Leiden

On-site

EUR 38,000 - 61,000

Full time

3 days ago

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Job summary

Johnson & Johnson in Leiden seeks an Associate Specialist QA to ensure GMP compliance throughout product introduction and lifecycle in the manufacturing environment. You will work closely with Operations, Quality Control, Engineering, and Development to support quality systems, batch releases, documentation management, and change control processes.

You will drive continuous improvement and uphold a strong quality culture, enabling timely product releases while maintaining regulatory compliance

Qualifications

Bachelor’s degree or higher in a life sciences field.
Minimum 2 years in a GMP-regulated environment within QA/QC/manufacturing.
Strong knowledge of GMP regulations, quality systems, batch release, change control.
Experience in biotech/pharma preferred; gene therapy knowledge a plus.
Excellent analytical, problem-solving and communication skills; English required; Dutch a plus.

Responsibilities

Perform electronic batch record reviews and support batch disposition per GMP requirements.
Review and release raw materials while maintaining material master data in quality systems.
Assess, approve, and verify change controls for process changes.
Review and approve GMP documents, including master batch records and validation reviews.
Prepare release packages for Qualified Persons (QP) and support product release processes.
Participate in local and global quality projects and promote a culture of quality and compliance.