Quality Systems Specialist, Hoofddorp, Noord-Holland

The Company
Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety.

Role Description
As a Quality Systems Specialist, you will support the Quality Management System by managing GMP training processes and document control activities. This role ensures compliance through accurate training records, controlled documentation, and proper archival of quality records. You will work with Learning Management Systems (LMS) and document management systems, support audits, and contribute to inspection readiness within a regulated biotech or pharmaceutical environment.

Responsibilities

• Assist with the daily operations and administration of the LMS platform, including user management, training setup, and report generation.
• Support the scheduling, delivery, and tracking of GMP training courses.
• Manage controlled documents and quality records, including archiving, retrieval, and retention activities, in accordance with regulatory and company standards.
• Execute document change control processes, review controlled documents for accuracy, and ensure timely implementation of updates.
• Support audit and inspection readiness by maintaining accurate records and facilitating document reviews.
• Provide guidance and informal training to staff on document control procedures.

• Bachelor's degree in Life Sciences or a related field preferred.
• At least 2 years of experience working within a GMP environment in biotech, biologics, or pharmaceuticals.
• Familiarity with quality systems, GMP training, and document management procedures.
• Experience with electronic document management or LMS platforms such as Veeva, Documentum, or comparable systems.
• Strong understanding of GMP principles, SOPs, and regulated quality processes.
• Proficient in MS Word, Excel, PowerPoint, and Adobe Acrobat, with good data reporting skills.
• Excellent organizational skills with attention to detail.

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