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- Tasks: Conduct audits to ensure compliance with quality assurance processes and regulatory guidelines.
- Company: Join Thermo Fisher Scientific, a leader in making the world healthier, cleaner, and safer.
- Benefits: Enjoy a full-time role with opportunities for career growth and international travel.
- Why this job: Make a real impact on health outcomes while working in a dynamic and innovative environment.
- Qualifications: Bachelor's degree and 2+ years of QA experience required; GCP experience preferred.
- Other info: Embrace our 4i values: Integrity, Innovation, Intensity, Involvement.
The predicted salary is between 36000 - 60000 £ per year.
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
We have a vacancy for a Quality Assurance Auditor in the EMEA region. This is a full-time permanent role. Country location preferred: UK.
Summary of Role:
Conducts complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting quality and/or regulatory compliance, supports determination of root cause of non-conformance and assists in developing strategies to address issues. May perform technical document review and other GxP activities in support of project work or company process. Provides finished audit reports to management. Plans and delivers billable quality services for clients and projects.
A Day in the Life:
- Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management.
- Provides GxP consultation and support to project teams and external clients.
- Leads process audits and may participate as a co-auditor in more complex system audits.
- Performs other types of QA audits or activities (database audits, clinical study report audits, sample results tables, process improvement).
- Serves as a knowledgeable resource to operational departments on audit or quality assurance subject matter.
- Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings.
Education and Experience:
Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
GCP/Auditing Experience.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, and Abilities:
- GCP experience.
- Experience working in a GCP Environment.
- Auditing experience.
- 25% travel required internationally.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
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QA Auditor II, null employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Auditor II, null
✨Tip Number 1
Familiarize yourself with GCP guidelines and regulations. Understanding these standards will not only help you in the interview but also demonstrate your commitment to quality assurance in clinical research.
✨Tip Number 2
Network with professionals in the QA field, especially those who have experience in GCP environments. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of audits you've conducted or participated in. Highlighting your hands-on experience will showcase your ability to handle the responsibilities of the QA Auditor II position.
✨Tip Number 4
Research Thermo Fisher Scientific's recent projects and initiatives. Being knowledgeable about the company’s mission and values will help you align your answers during the interview and show your genuine interest in the role.
We think you need these skills to ace QA Auditor II, null
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the QA Auditor II position at Thermo Fisher Scientific. Understand the key responsibilities, required skills, and the company's mission to ensure your application aligns with their expectations.
Highlight Relevant Experience: In your CV and cover letter, emphasize your previous QA experience, particularly in GCP environments. Provide specific examples of audits you've conducted and how they contributed to compliance and quality assurance.
Showcase Your Skills: Make sure to highlight your knowledge of regulatory guidelines and quality assurance processes. Mention any relevant certifications or training that demonstrate your expertise in the field.
Align with Company Values: Reflect on Thermo Fisher Scientific's 4i values: Integrity, Innovation, Intensity, and Involvement. Incorporate these values into your application to show that you resonate with their culture and mission.
How to prepare for a job interview at TN United Kingdom
✨Understand the Role and Responsibilities
Make sure you have a clear understanding of the QA Auditor II role. Familiarize yourself with the specific responsibilities, such as conducting audits and ensuring compliance with quality assurance processes. This will help you articulate how your experience aligns with their needs.
✨Showcase Your GCP Experience
Since GCP experience is crucial for this position, be prepared to discuss your previous work in a GCP environment. Highlight specific examples where you contributed to quality assurance and compliance, demonstrating your expertise in this area.
✨Emphasize Problem-Solving Skills
The role involves identifying issues impacting quality and regulatory compliance. Be ready to share examples of how you've successfully identified root causes of non-conformance and developed strategies to address them. This will showcase your analytical skills and proactive approach.
✨Align with the Company Values
Thermo Fisher Scientific values integrity, innovation, intensity, and involvement. Think of ways you can demonstrate these values through your past experiences. Showing that you resonate with their culture will make a positive impression during the interview.
