QC Laboratory Assistant

Prothya Biosolutions; Brussel Hoofdstad; Sur place; EUR 32 000 - 46 000; Plein temps

Résumé du poste

Prothya Biosolutions is seeking an Administrative Assistant - QC Laboratory to support our Quality Control team in a GMP-regulated environment. You will manage documentation, coordinate training, and provide daily administrative support to ensure compliant operations.

Ideal candidates have a Bachelor's degree, experience in pharmaceutical settings, strong MS Office skills, and ability to work with QC/QA stakeholders.

Qualifications

• Bachelor's degree in a related field required or preferred.
• Experience in pharmaceutical, biotechnology, healthcare, or laboratory environment desirable.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Fluent in French or Dutch with strong English, both written and spoken.

Responsabilités

• Prepare, format, and maintain controlled documents and procedures in accordance with company standards.
• Initiate and manage document workflows within the Electronic Document Management System (EDMS).
• Support approval and release of documents and ensure archiving of laboratory documentation.
• Review analytical results and verify compliance against specifications and acceptance criteria.
• Register and maintain training records; coordinate and deliver training on basic QC administrative processes.
• Support KPI monitoring, provide feedback on discrepancies, and assist in process improvements.

Connaissances

MS Office

Documentation management

GMP knowledge

Quality systems

SAP

MasterControl

Communication

French or Dutch fluency

English proficiency

Formation

Bachelor's degree in Office Management, Business Administration, Translation, or related field

Outils

SAP

MasterControl

EDMS

Description du poste

About the Role

Are you highly organized, detail-oriented, and interested in working in a GMP-regulated pharmaceutical environment?

We are looking for an Administrative Assistant - QC Laboratory to support our Quality Control team. In this role, you will be responsible for managing key administrative and documentation activities, supporting training coordination, reviewing laboratory records, and contributing to quality and compliance processes.

You will work closely with QC laboratory teams, QA, and other stakeholders to ensure efficient operations and compliance with internal procedures and regulatory requirements.

Key Responsibilities

Documentation & SOP Management

• Prepare, format, and maintain controlled documents and procedures in accordance with company standards.
• Initiate and manage document workflows within the Electronic Document Management System (EDMS).
• Support the approval and release of documents in the system.
• Ensure proper archiving and maintenance of laboratory documentation.

Data Review & Administrative Support

• Review analytical results and associated documentation, including raw data and audit trails.
• Verify compliance of results against defined specifications and acceptance criteria.
• Archive laboratory worklists and related records.
• Monitor and follow up daily worklists in collaboration with the QC Improvement & Release Team.
• Provide day-to-day administrative support to QC operations.

Training Coordination

• Register and maintain training records in the training management system.
• Coordinate and deliver training related to basic QC administrative processes.
• Maintain competency matrices and training compliance records.
• Track employee qualifications and training status.

Quality Systems Support

• Support the Senior Quality Technician QC in managing quality records, including Events, OOX, CAPAs, and MOCs.
• Collect, organize, and upload supporting documentation into MasterControl.
• Ensure proper tracking and follow-up of quality-related documentation.
• Provide constructive feedback when discrepancies or deviations are identified during reviews.
• Ensure timely follow-up of comments and open actions.
• Collaborate effectively with QC and QA stakeholders.
• Contribute to continuous improvement initiatives within the QC department.
• Support KPI monitoring and reporting activities.
• Assist in the development and implementation of process improvements.

Key Stakeholders

• QC Improvement & Release Team
• QC EM/Utilities Team
• QC Operations Team
• QA Operations
• QA Systems

What We're Looking For

Education

• Bachelor's degree in Office Management, Business Administration, Translation, or a related field.

Experience

• Previous experience in an administrative support role.
• Experience within the pharmaceutical, biotechnology, healthcare, or laboratory environment is highly desirable.
• Knowledge of Quality Control laboratory operations is required.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Fluent in French or Dutch with a good command of English, both written and spoken.
• Knowledge of GMP requirements, quality systems, and SOP management is an asset.
• Strong organizational and communication skills.
• High level of accuracy and attention to detail.
• Ability to manage recurring administrative tasks efficiently.
• Experience with SAP and/or MasterControl is considered a strong advantage.
• Team-oriented, proactive, and flexible approach.

Why Join Us?

This is an excellent opportunity to join a dynamic Quality Control Laboratory where your administrative expertise will play a key role in supporting compliance, operational excellence, and product quality within a fast-paced pharmaceutical environment.

Ready to make a difference in quality and compliance? We look forward to hearing from you.