QC 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 QC Systems Specialist you will responsible for the full lifecycle management of Quality Control systems and laboratory equipment, ensuring GMP compliance, system availability, and data integrity. The role acts as a technical SME for QC systems, supports audits and inspections, and drives continuous improvement across QC processes and validation activities.

Responsibilities

• Manage the entire lifecycle of microbiology QC systems, including calibration, maintenance, and validation.
• Coordinate the introduction of new microbiological systems and ensure timely implementation.
• Act as the primary technical resource for microbiology-related issues, providing guidance to the QC team.
• Train new microbiology personnel and support continuous team development.
• Troubleshoot microbiological equipment and method issues to minimize downtime and delays.
• Organize daily tasks to maintain efficient testing workflows and timely release of products.
• Ensure all microbiological testing complies with GMP, safety policies, and regulatory standards.
• Lead investigations into deviations, CAPAs, and quality issues, contributing to the ongoing improvement of microbiology processes.

Requirements

• Degree in microbiology, biology, or related field.
• Significant experience in microbiological testing within a regulated environment.
• Knowledge of GMP, validation, and laboratory systems.
• Strong troubleshooting and problem-solving skills.
• Excellent communication and team collaboration abilities.

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