At a Glance
- Tasks: Conduct audits to ensure compliance with protocols and regulations in clinical research.
- Company: Join Celerion, a leading global contract research organisation in Belfast.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and quality improvement.
- Why this job: Make a real impact in clinical research and help bring new drugs to market faster.
- Qualifications: Bachelor's degree and 2-5 years of quality assurance experience required.
The predicted salary is between 30000 - 40000 £ per year.
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion offers one of the most experienced clinical pharmacology research networks in the industry. Celerion, a leading global contract research organization, seeks a Quality Assurance Auditor to support our rapidly growing Data Management and Biometrics department. The successful candidate will have Quality Assurance expertise within a GCP environment. This role will be located at our Belfast, Northern Ireland facility.
The role of the Quality Assurance Auditor is to assess and assure study, project and process compliance with protocols, Controlled documents, and applicable regulations and guidelines through audits.
Responsibilities:
- Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits).
- Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
- Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; Detect quality issues and the need for CAPAs and evaluate deviations.
- Assist with the preparation for and hosting of client audits and/or regulatory inspections.
- Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits.
Qualifications:
- Bachelors degree in science, IT, business, or similar.
- 2-5 years of quality/laboratory/clinical experience.
- Excellent oral and written communication skills.
- Ability to organize and manage multiple priorities.
- Excellent time management skills.
- Attention to detail, tactful, and diplomatic.
- Proficiency in using electronic data and computerized systems.
- Ability to travel, as needed.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. If you would like more information about how your data is processed, please contact us.
Quality Auditor/Quality Assurance in Belfast employer: Celerion
Celerion is an exceptional employer that fosters a dynamic and innovative work culture, particularly in our Belfast facility where the Quality Assurance Auditor role is based. We prioritise employee growth through continuous training and development opportunities, ensuring our team members are equipped to excel in their careers while contributing to meaningful clinical research. With a commitment to quality and compliance, Celerion offers a supportive environment that values collaboration and professional relationships, making it an ideal place for those seeking rewarding employment in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Auditor/Quality Assurance in Belfast
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Celerion looking for candidates who are engaged and informed.
We think you need these skills to ace Quality Auditor/Quality Assurance in Belfast
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Celerion. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Celerion
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Celerion’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
