Clinical Quality Assurance Specialist
hace 2 semanas
Overview
At QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. As a global leader in the field, we're constantly seeking talented individuals to join our team and contribute to our mission. Our employees are our most valuable asset, and we're dedicated to creating an environment that fosters growth, collaboration, and excellence.
Position Description
An exciting opportunity has arisen within our Manchester Quality Assurance team. The successful candidate will be responsible for ensuring the quality and compliance of clinical trial activities, working closely with the Clinical Affairs team to ensure seamless execution. This role will involve representing Clinical QA as a member of project teams, supporting qualification and performing independent QA audits of clinical study sites, and participating in the QIAGEN internal audit program.
Key Responsibilities
• Work with the Clinical Affairs team to ensure compliance during trial activities, including 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.
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.
What We Offer
At QIAGEN, we're committed to creating an environment that inspires innovation, collaboration, and excellence. We offer a dynamic and diverse work environment, opportunities for growth and development, and a competitive compensation package. If you're passionate about making a real difference in science and healthcare, we encourage you to apply for this exciting opportunity.
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