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- Tasks: Support quality assurance activities and conduct audits in a dynamic environment.
- Company: Join Thermo Fisher Scientific, a leader in the life sciences sector.
- Benefits: Inclusive workplace, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring compliance and quality.
- Qualifications: Must meet UK Qualified Person status with experience in biological products.
- Other info: Be part of a supportive team that values diversity and innovation.
The predicted salary is between 36000 - 60000 £ per year.
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Job Description:
Position Summary: The QP will provide support to all appropriate and relevant activities within Fisher BioServices, UK. The job has three primary functions: QP certifications and declarations, technical contribution to the operations of FBS UK, and conducting audits. The jobholder will form part of the 'Quality team', supporting the QP certification activities, maintaining an up to date awareness of current legislation, and contributing to QP policies.
Key Responsibilities:
- To provide QP certification in compliance with regulatory requirements and if required, specific client technical agreements.
- To perform QP GMP declarations including on site audits if required, in support of importation activities.
- To perform UK QP Oversight activities.
- Conducting internal and external audits as required.
- Provision of GMP training.
- To provide information and training on the QP roles and responsibilities to FBS personnel.
- Where needed, support Business Development/Sales and Project Management at pre-contract stage to assess new contracts.
- To maintain awareness of the regulatory issues affecting the clinical supplies process keeping relevant FBS colleagues informed where appropriate.
- To provide technical advice and support in the preparation of Technical Agreements.
- Support client and regulatory audits with QP input.
- May be required to perform off site work where necessary.
- Travels as required.
Minimum Requirements/Qualifications:
- Meets the UK requirements for Qualified Person status.
Hiring Criteria:
- Experience in acting as a QP for IMPs (experience in biological products preferred).
- Knowledge of pharmaceutical development process desirable.
Staff QA Engineer employer: myGwork - LGBTQ+ Business Community
Contact Detail:
myGwork - LGBTQ+ Business Community Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Staff QA Engineer
✨Tip Number 1
Network like a pro! Reach out to current employees at Thermo Fisher Scientific on LinkedIn or through industry events. A friendly chat can give us insights into the company culture and maybe even a referral!
✨Tip Number 2
Prepare for the interview by brushing up on your QP knowledge and recent regulatory changes. We want to show that we’re not just qualified, but also passionate about staying updated in the field.
✨Tip Number 3
Practice common interview questions related to quality assurance and audits. We can even do mock interviews with friends or colleagues to build confidence and refine our answers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows we’re serious about joining the team at Thermo Fisher Scientific.
We think you need these skills to ace Staff QA Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Staff QA Engineer role. Highlight your experience with QP certifications and audits, and don’t forget to mention any relevant training you've provided. We want to see how your skills match up with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how your background makes you a perfect fit for our team. We love hearing personal stories that connect your experience to the role.
Showcase Your Regulatory Knowledge: Since this role involves compliance with regulatory requirements, make sure to showcase your knowledge of current legislation in your application. We’re keen to see how you stay updated and how you can contribute to our QP policies.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team at Thermo Fisher Scientific.
How to prepare for a job interview at myGwork - LGBTQ+ Business Community
✨Know Your QP Stuff
Make sure you brush up on your knowledge of Qualified Person (QP) responsibilities and the regulatory requirements. Be ready to discuss your experience with IMPs and any relevant biological products, as this will show you're the right fit for the role.
✨Showcase Your Audit Experience
Prepare examples of your past audit experiences, both internal and external. Highlight how you've contributed to compliance and quality assurance in previous roles, as this will demonstrate your capability to handle the auditing responsibilities at Thermo Fisher Scientific.
✨Stay Updated on Regulations
Familiarise yourself with current legislation affecting the clinical supplies process. Being able to discuss recent changes or challenges in the industry will show that you’re proactive and knowledgeable, which is crucial for a role that involves maintaining compliance.
✨Be Ready for Technical Questions
Expect technical questions related to QP certifications and GMP declarations. Prepare to explain your thought process and decision-making in past situations, as this will help interviewers gauge your problem-solving skills and technical expertise.