QA Document Control Specialist, Hoofddorp, Noord-Holland

Job Title: QA Document Control Specialist
Location: Hoofddorp, Netherlands
Industry: Biotech / Pharmaceutical
Employment Type: Full-time

About the Company
Our client is a fast-growing biotech company based in Hoofddorp, leading the way in advanced cell therapy. With a state-of-the-art facility and a clear mission to bring transformative treatments to patients, they operate in a fast-paced, highly regulated environment. Their culture is collaborative, purpose-driven, and focused on continuous innovation.

About the Position
As a QA Document Control Specialist, you’ll be a key player in maintaining the integrity and compliance of GMP documentation. This role requires a high level of attention to detail and a strong understanding of document lifecycle in a regulated setting. You'll work closely with QA, manufacturing, and other departments to ensure all controlled documents and materials meet quality standards and regulatory requirements.

Responsibilities

• Verify controlled issued batch documents, label packages (including final product labels), and logbooks in accordance with cGMP standards.

• Ensure QA-issued documents are complete, accurate, and compliant.

• Track usage and support timely consumption of consumables and GMP materials.

• Identify and escalate compliance gaps in the controlled issuance process.

• Support deviation investigations and assist in developing corrective action plans.

• Contribute to strategic initiatives that improve document control processes.

• Participate in internal and external audits by providing required documentation and insight.

• Provide cross-training to colleagues and support internal knowledge sharing.

• Perform additional quality-related duties as assigned or delegated.

Requirements

• Minimum 2 years of experience in document management within a GMP-regulated environment.

• Solid understanding of cGMP guidelines and documentation standards.

• Advanced English communication skills (written and verbal).

• Excellent attention to detail and strong organizational skills.

• Ability to manage deadlines and prioritize tasks in a dynamic environment.

• Comfortable interacting with stakeholders across different levels and departments.

• Proactive, solution-focused mindset with a drive for process improvement.

• Experience supporting audits and handling deviations is a plus.

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