QC Biologist Specialist

Randstad Belgium; Waals-Brabant; Hybride; EUR 48 000 - 62 000; Plein temps

Résumé du poste

Randstad Belgium is seeking a QC Biologist Specialist for a 6-month project in Walloon Brabant. The role focuses on QC of biologics and ensuring GMP-compliant laboratory operations throughout product development.

You will collaborate with the QC Biologics management, Team Leaders and QA to maintain documentation, investigations, and CAPAs while supporting new process implementations and regulatory submissions. Hybrid work setup applies.

Qualifications

• Master's degree in Analytical Chemistry / Biochemistry or equivalent.
• Minimum 5 years in QC for biologics, esp. monoclonal antibodies.
• GMP experience in a pharmaceutical QC lab is mandatory.
• Fluent in English and French.

Responsabilités

• Manage end-to-end sample tracking (release, in-process, stability) in GMP systems.
• Handle deviations, CAPAs, investigations and change controls.
• Coordinate with Team Leads and stakeholders for planning and priorities.
• Participate in meetings with Production and MSAT to align lab activities.
• Update and review lab documentation and methods; coach team.
• Support launches and document data sharing for authorities.

Connaissances

Quality control

GMP compliance

Laboratory leadership

Documentation

Planning & coordination

Problem solving

Formation

Master's in Analytical Chemistry / Biochemistry

Outils

LIMS

Analytical methods

Description du poste

We are looking for a QC Biologist Specialist for a pharmaceutical company in Walloon Brabant!

If you are an experienced scientific professional with a strong background in biologics and quality control, this 6-month, project-based opportunity might be the perfect fit for you.

About the Role:

In this role, you will support the implementation of Biologics-based products from Phase III throughout the product life cycle. Working closely with the QC Biologics management team, Team Leaders, and technicians, you will provide critical scientific expertise and ensure smooth laboratory operations.

Key Responsibilities:

• Manage end-to-end sample tracking (release, in-process, stability) through GMP systems, from reception to destruction.
• Handle deviations, investigations, corrective/preventive actions (CAPAs), and change controls.
• Ensure smooth internal communication regarding urgencies and priorities, adjusting planning with Team Leads and various stakeholders.
• Actively participate in meetings with Production and MSAT teams to ensure close coordination with the lab.
• Update and review laboratory documentation, including analytical methods, instructions, and coaching modules.
• Support product launches, new process implementations, and prepare necessary documentation for authorities (data sharing, batch updates, sampling plans).

Your Profile:

• Education: Master's degree in Analytical Chemistry (applied to biological products / NBE), Biochemistry (CBA, PCR, Elisa, etc.), Biology, or equivalent.
• Experience: Minimum 5 years in a similar position with expertise in the pharmaceutical analysis of biological products, specifically monoclonal antibodies.
• GMP Knowledge: Proven experience working in a QC GMP environment is mandatory.
• Hard Skills: Strong track record in documentation creation/updating, planning, monitoring, and conducting investigations in collaboration with QA.
• Soft Skills: Excellent organizational and leadership skills, stress resistance, continuous improvement mindset, and a problem-solving approach.
• Languages: Fluent in both English and French.

Practical Details:

• Duration: 6 months, starting ASAP.
• Schedule: Full-time (8 hours/day, indicatively 09:00 to 18:00).
• Work Model: Hybrid setup with 3 days on‑site in Walloon Brabant and 2 days working from home.