We are on the lookout for a Sr QA Associate to strengthen the Quality Assurance team and ensure that the company quality standards and customer expectations are met.

Besides meeting these expectation you will also be pivotal in the continuous improvement of the QMS system and the organization.

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

The Sr QA Associate will be responsible for:

• Review and approve quality documents, including CAPAs (Corrective and Preventive Actions), NCRs (Non-Conformance Reports), and Planned/unplanned deviations.
• Ensure that all products meet the predefined requirements (ISO9001 and customer specification) and company quality standards.
• Assist in the preparation and execution of external and internal audits.
• Maintain and improve the Quality Management System (QMS), ensuring it remains compliant with relevant regulations and customer expectations.
• Identify potential areas for quality improvement and work with cross-functional teams to resolve issues.
• Contribute to risk management activities, including risk assessments and failure mode effect analysis (FMEA).
• Track, analyze, and report quality metrics to identify trends and drive continuous improvement.

The successful candidate will meet the following criteria:

• Requires Bachelor level education in Science or Engineering related field.
• Minimum 5 years’ experience in Quality Assurance in an ISO 9001 and/or GMP related industry.
• Good oral and written communication and presentation skills (Dutch and English).
• Must be resourceful and self-motivated.
• Focus and attention to detail is critical.

Preferred :

• Experience with ISO17025, ISO13485 or equivalent standards.

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.