Quality Assurance Specialist
3 weeks ago
We are on a mission to make a real difference in science and healthcare. Our most valuable asset are our employees - more than 6000 in over 35 locations around the world.
An exciting new role has arisen within the QIAGEN Manchester Quality Assurance team. The successful candidate will take on responsibility for quality and compliance oversight of the activities performed by the Clinical Affairs team at QIAGEN, in support of the testing and registration of diagnostic tests covering a diverse portfolio of indications.
Key Responsibilities:- Work with members of the Clinical Affairs team to ensure compliance during trial activities - e.g. closure of deviations, complaints etc.
- Represent Clinical QA as a member of project teams for planned and ongoing clinical trials, including Quality review of clinical relevant documentation.
- Support qualification and perform independent QA audits of clinical study sites.
- Proven working experience as a Clinical Research Associate or similar with knowledge of relevant regulations, standards, guidelines and best practice.
- Desirable: working knowledge of In Vitro Diagnostic or Medical Device Regulations.
- Desirable: experience as an Auditor and/or Subject Matter Expert in regulatory inspections.
- Willingness and availability to travel internationally (Europe + USA) up to 10%.
- Ability to work independently while exercising good judgement and decision making within defined practices and policies.
We are looking for a highly motivated and experienced Quality Assurance Associate to join our team. If you have a passion for quality and compliance, and are looking for a new challenge, please apply.
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