
Senior QA Specialist
hace 3 semanas
Company Overview
At the heart of QIAGEN's business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare.
Position Description
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, such as closure of deviations and complaints.
* 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.
* Participate in the QIAGEN internal audit program.
* Review Clinical Affairs SOPs.
Position Requirements:
* Degree qualification in a relevant subject, or equivalent employment experience.
* 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.
* Excellent communication and interpersonal skills with the ability to work effectively with multinational/ cultural teams and individuals.
Salary: £60,000 - £80,000 per annum, depending on experience.
Benefits: At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions.
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