Quality Assurance Associate
4 weeks ago
Overview
We are seeking a highly skilled Quality Assurance Associate to join our team at QIAGEN. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and compliance of our clinical trials and diagnostic tests.
Key Responsibilities:
- Collaborate with the Clinical Affairs team to ensure compliance with regulatory requirements and company policies.
- Represent Quality Assurance 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 and knowledge of clinical regulations, standards, guidelines and best practice e.g. CFR 812, BIMO, ISO standards, ICH GCP.
- Demonstrable working knowledge of global In Vitro Diagnostic Regulations (EU IVDR, US 21CFR820).
- Qualified Auditor and experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits e.g. NB audit.
- 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 value our employees and offer a range of benefits to support their growth and well-being. These include:
- Possibility to develop in an international company.
- Attractive pension.
- Private Healthcare.
- Private Dentalcare.
- Gym membership contribution.
- Access to an Employee Assistance Programme.
- A range of retail discounts and offers.
- Opportunity to join internal QIAGEN communities.
- Enhanced maternity package.
- Flexible working options.
- Bonus/commission.
- 25 days annual leave (potential to increase linked to service).
We are an equal opportunities employer and welcome applications from all qualified candidates.
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