We are on the lookout for a Document controller to strengthen the Quality Assurance team and assist in the processing of documentation requests.

In this role communication with multiple departments, informing stakeholders (local and international) and contribute to project teams is an important part of the role. You will work closely with Quality Assurance colleagues to ensure the changes are accurate and are made effective in a timely manner.

You will be part of a team of 4 QA co-workers and report to the Sr. Quality Manager.

The Document controller will be responsible for:

• Managing the training program and change control process
• Prepares and publishes approved documentation in a timely manner to meet established deadlines (paper and electronic)
• Electronically store, retrieve, update, and distribute engineering and manufacturing documentation.
• Review and approve quality documents, including CAPAs (Corrective and Preventive Actions), NCMRs (Non-Conformance Material Records), and Planned/Unplanned deviations.

The successful candidate will meet the following criteria:

• Requires Bachelor level education in Science or Engineering related field.
• Minimum 2-4 years’ experience in Quality Assurance in an ISO 9001 and/or GMP related environment. Pre = experience  ISO17025
• Good oral and written communication and presentation skills (Dutch and English).
• Focus and attention to detail is critical.

Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, fast-paced environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Breda, Netherlands.