Hytest is a manufacturer of high-quality antibodies and antigens for the IVD industry. We are a market leader in the development and production of reagents used for diagnosing acute myocardial infarction, heart failure, sepsis, and other diseases. Our mission is to deliver antibodies and antigens for improved patient outcomes. For COVID-19, we quickly developed best-in-class antibodies that are now utilised in several COVID-19 Antigen tests globally.
Hytest is a proud and responsible employer to more than 150 employees worldwide. Our team consists of experts in different areas and employee development is one of the key drivers for Hytest. We offer meaningful work in a company that changes lives for better, competitive salary and benefit package, ongoing learning, work in a dedicated and friendly team, and flexibility in remote work arrangements. We are now looking for the new specialist to join our team!
Quality Assistant
Job Summary
The Quality Assistant's role is fixed-term. Quality Assistant supports Hytest in maintaining high standards of product quality and ensuring compliance with applicable regulatory requirements. This role is responsible for assisting with quality assurance activities, regulatory compliance, product release processes, manufacturing related tasks, equipment control and audit support.
Key Responsibilities
Quality & Compliance
- Assist in maintaining and improving the Quality Management System (QMS)
- Ensure adherence to internal quality standards and external regulatory requirements
- Support documentation control, including SOPs, policies, and records
- Contribute to the monitoring, analysis, and reporting of quality performance metrics. Support compliance with applicable laws, regulations, and industry standards
- Assist in preparing and maintaining regulatory documentation and submissions
- Coordinate product‑related testing activities and ensure proper documentation
- Performing equipment and material control related tasks
- Assist and support in the preparation, documentation, investigation, implementation and monitoring of corrective actions and audits
- Assist and support in complaint handling and related documentation
Final Product Release
- Participate in the final review and release of products to ensure compliance with quality standards
- Verify documentation completeness and accuracy prior to release
- Coordinate with production and quality teams to resolve any release-related issues
Other duties
- Provide general support to the Quality & Compliance Department
- Participate in continuous improvement initiatives
- Perform other related tasks and participate in quality and compliance projects as required
Requirements:
- Preferably: Bachelor’s degree in a relevant field (e.g., Life Sciences, Quality Management, Engineering, or similar)
- Previous experience or good understanding of quality, compliance, or regulatory role
- Familiarity with quality systems and regulatory standards (e.g., ISO, GMP)
- Strong attention to detail and organizational skills
- Good communication skills
- Continuous improvement mindset
- Fluent English