QA Specialist – Batch Review & Documentation
Location: Hoofddorp, NLDuration: 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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QA Specialist – Batch Review & Documentation
Location: Hoofddorp, Noord-Holland
Sector: Pharmaceuticals
About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.