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# Associate Specialist QA

- **Company:** Stichting Leiden Bio Science Park Foundation
- **Location:** TILBURG, Netherlands
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Document Management Systems, User-Centered Design
- **Published:** September 18, 2026
- **Apply:** https://jobs.leidenbiosciencepark.nl/vacancies/associate_specialist_quality_assurance_01m2qrac33cad4bpwvqt4jp2k0

## About the Role

* Bachelor's degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related scientific discipline.
 * Minimum of 2 years of experience in a GMP-regulated environment within Quality Assurance, Quality Control, Manufacturing, or a related pharmaceutical/biotechnology function.
 * Strong understanding of GMP regulations, quality systems, batch release processes, change control, and compliance requirements.
 * Experience within the biotechnology or pharmaceutical industry; knowledge of gene therapy and biological products is considered an advantage.
 * Excellent analytical, problem-solving, and decision-making skills, with strong attention to detail and the ability to work independently.
 * Strong communication, influencing, and stakeholder management skills, with excellent written and verbal English; Dutch language skills are a plus.

Preferred Skills:

Accountability, Administrative Support, Compliance Management, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Report Writing

## Description

* Perform electronic batch record reviews and support batch disposition activities in accordance with GMP requirements.
 * Review and release raw materials while maintaining accurate material master data within quality systems.
 * Assess, approve, and verify change controls to ensure compliance and effective implementation of process changes.
 * Review and approve GMP documents, including master batch records, validation reviews, and shipment-related documentation.
 * Prepare release packages for Qualified Persons (QP) and support product release processes.
 * Participate in local and global quality projects, support process optimization initiatives, and promote a culture of quality and compliance throughout the organization.


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