QA Specialist – Batch Review Documentation

Location : Hoofddorp, NL
Duration : Until end of 2025 (with potential for extension)

About the Company
Our client is a pioneering biopharmaceutical company focused on advancing cell therapy for the treatment of cancer. Based in Hoofddorp, they are part of a global organization committed to bringing innovative immunotherapies to patients with urgent medical needs. The company operates in a fast-paced, purpose-driven environment where teamwork, agility, and precision are key to delivering life-saving therapies on time.

About the Position
We are currently looking for a detail-oriented QA Specialist to join the QA Operations Review & Disposition team. This role is ideal for someone with a strong foundation in GMP environments who thrives in routine-focused work and has a sharp eye for detail. As part of a dedicated quality assurance team, you will play a critical role in ensuring the accuracy and compliance of manufacturing records for advanced therapeutic products.

Responsibilities
-Review manufacturing, environmental monitoring, and quality control records for in-process and finished products (both paper-based and electronic).
-Prepare batch documentation packages for quality disposition and Qualified Person (QP) release.
-Identify and escalate deviations from approved procedures.
-Support various administrative tasks including binder compilation, archiving, and team logistics.
-Work in alignment with tight production timelines to ensure timely delivery of patient-critical therapies.
-Contribute to maintaining compliance with GMP standards and internal quality procedures.

Requirements
-BSc degree or equivalent Associate’s degree with relevant experience.
-Experience in a GMP-regulated environment
-Solid understanding of Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
-Comfortable working with electronic systems (e.g., ERP, EBR, LIMS) and Microsoft Office applications.
-Strong attention to detail, accuracy, and consistency in documentation.
-Able to learn quickly, work independently after training, and thrive in a structured, deadline-driven role.

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