QA Documentation Specialist

Quality Operations Documentation Specialist

About the Company

Our client is a leading biopharmaceutical organisation at the forefront of advanced cell therapy manufacturing. Operating one of Europe's most innovative production facilities in the Amsterdam region, the company is dedicated to developing and manufacturing life-changing therapies for patients with serious diseases. Working in a highly regulated GMP environment, you will be part of a collaborative and fast-paced team focused on quality, innovation, and continuous improvement. The organisation continues to invest heavily in its people, technology, and manufacturing capabilities, offering excellent opportunities for long-term career development within the rapidly growing cell and gene therapy sector.

About the role

As a Quality Operations Documentation Specialist, you will be responsible for the controlled issuance and verification of GMP documentation, supporting manufacturing and operational teams in maintaining full compliance with regulatory and quality standards. You will work closely with cross-functional stakeholders to ensure documentation processes are executed efficiently while driving continuous improvements across quality systems.

Key responsibilities

• Verify and issue controlled batch records, label packages, and final product labels in accordance with cGMP requirements.
• Review and control GMP logbooks and associated documentation.
• Ensure the accuracy, completeness, and compliance of QA-issued documents.
• Manage the timely consumption and reconciliation of GMP materials and consumables used within documentation processes.
• Identify, investigate, and escalate compliance issues related to document control activities.
• Support deviation investigations and implement effective corrective and preventive actions (CAPAs).
• Contribute to process improvement initiatives aimed at increasing efficiency and compliance within document issuance operations.
• Provide guidance and training to colleagues and internal customers on document control procedures and GMP requirements.
• Collaborate with operational, quality, and manufacturing teams to support business objectives and regulatory compliance.

What you'll bring

• HBO or WO degree in Life Sciences, Quality, Biotechnology, Chemistry, Pharmacy, or a related field.
• Minimum 2 years of experience in document management, document control, or quality operations within a regulated environment.
• Strong knowledge of GMP and quality systems within the pharmaceutical, biotech, or medical device industry.
• Excellent attention to detail and ability to work accurately under time-sensitive conditions.
• Strong communication skills with the ability to engage effectively with stakeholders at all levels.
• Experience supporting investigations, deviations, and continuous improvement initiatives is advantageous.
• Fluent English communication skills, both written and verbal.
• Positive, proactive, and collaborative mindset.

What's on offer

Hays Detachering | This is a project that will start with a contract for 12 months through Hays. In this position, you will get a competitive salary starting at €58000 gross per year, excluding shift allowance and your travel expenses are covered. This position operates in a slight shift pattern, working one weekend every 6 weeks.

What you need to do now

If you're interested in this role, click 'Apply Now' to forward an up-to-date copy of your CV, or contact us for more information. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.