Quality Release Specialist

The Quality Release Specialist at Clinigen is responsible for managing operational tasks within the Quality Management System (QMS). This includes collaborating with various departments to investigate, review, and close records in the electronic QMS. They also create, review, and approve standard operating procedures, maintain quality documentation, and participate in regulatory audits and inspections, ensuring compliance and continual improvement.

To succeed as a Quality Release Specialist at Clinigen, candidates typically require a degree in a relevant field, such as life sciences or quality assurance. Experience in quality management systems and regulatory compliance is often essential, along with strong analytical skills and attention to detail. Effective communication and the ability to work collaboratively across departments are also key qualifications for this role.

The Quality Release Specialist contributes to continual improvement at Clinigen by analyzing data trends and formulating reports based on their findings. They also identify process improvement opportunities and collaborate with various business areas to implement these enhancements, thereby fostering a culture of operational excellence within the organization.

As a Quality Release Specialist at Clinigen, employees enjoy numerous benefits, including 27 days of annual vacation plus bank holidays, a pension plan with employer matching, life assurance coverage, and access to a flexible benefits platform. Additional perks include independent financial advice services, shopping discounts, and recognition initiatives, making it a rewarding work environment.

At Clinigen, a Quality Release Specialist can expect ample opportunities for career growth and development. With the company's ongoing expansion and commitment to operational excellence, there are pathways available for advancement within quality management or broader operational roles, alongside opportunities to enhance skills through training and professional development programs.

When answering, focus on concrete examples of your past experiences with QMS. Discuss specific systems you've worked with, the types of documentation you've managed, and how you've ensured compliance with regulatory requirements.

Explain your familiarity with auditing procedures and outline your approach when you identify issues. Emphasize your proactive attitude towards resolving non-conformities and implementing preventive measures.

Discuss methods you’ve employed in the past to ensure that documentation remains up-to-date and complies with standards. Share examples of how you’ve organized records and conducted reviews to minimize errors.

Share your approach to task prioritization, perhaps mentioning how you assess the urgency of each task or use tools like project management software to keep track of deadlines and responsibilities.

Provide a specific example of a situation where you recognized a process that could be improved. Discuss the steps you took to implement changes and the outcome of those efforts.

Highlight your collaborative nature and give examples of successful team projects that enhanced quality management processes. Stress the importance of working together with cross-functional teams.

Explain your methods for keeping yourself informed, such as attending webinars, participating in industry associations, or subscribing to relevant publications. Mention your commitment to ongoing professional development.

Use the STAR method to structure your answer. Describe the challenge, the actions you took to address it, and the positive outcome. Focus on your problem-solving capabilities.

Discuss your experience in designing and delivering effective training programs. Share methods you’ve found successful for engaging team members and ensuring they understand and can implement quality procedures.

Share your passion for quality management and how it aligns with Clinigen’s mission. Discuss specific aspects of the company’s culture or values that appeal to you and how you see yourself contributing to their goals.