Associate Specialist QA

• 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.

• 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