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- Tasks: Join us as a QA Specialist, ensuring top-notch quality in biopharmaceutical manufacturing.
- Company: Be part of a leading biopharmaceutical services organisation making waves in cell and gene therapies.
- Benefits: Enjoy competitive pay, career growth, and the chance to work on impactful clinical projects.
- Why this job: Influence quality culture in a purpose-driven environment while developing your skills in an innovative field.
- Qualifications: A degree in a relevant scientific area and experience in GMP functions are essential.
- Other info: We value diversity and welcome applications from all backgrounds.
The predicted salary is between 36000 - 60000 £ per year.
We are currently looking for a Quality Assurance Specialist to join a leading biopharmaceutical services organisation based in the South West of the UK. Our client specialises in supporting the manufacture of cell and gene therapies (CGT) and biopharmaceuticals. As a Quality Assurance Specialist, you will play a key role in supporting the Pharmaceutical Quality System (PQS), collaborating across Quality, Production, and QC teams to ensure compliance across a range of innovative and regulated manufacturing projects.
KEY DUTIES AND RESPONSIBILITIES
- Support the Quality Manager and Senior QA Specialists in maintaining oversight of the PQS, including deviation and issue management, change control, validation activities, out-of-specification results, supplier oversight, and self-inspections.
- Complete reviews of production batch records and QC test data.
- Maintain and support the documentation control system, including SOPs, batch records, validation protocols, and QC reports.
- Ensure the timely investigation and closure of deviations, audit findings, and out-of-specification events.
ROLE REQUIREMENTS
- A Degree or higher level in a relevant scientific subject area (Pharmaceutical Chemistry / Quality Assurance / Quality Management).
- Proven experience in GMP functions across QA, QC, or Production.
- Demonstrated experience in GMP-regulated environments, including Quality Management Systems, risk management tools, deviation/CAPA processes, and document control.
- Familiarity with HTA, FDA, and UK/EU regulations, and previous exposure to CDMO or ATMP environments would be advantageous.
WHAT’S IN IT FOR YOU?
You will join a respected and growing organisation with global recognition in CGT and biopharmaceutical manufacturing. As a Quality Assurance Specialist, you will have the opportunity to influence quality culture, support impactful clinical projects, and further develop your career in a highly innovative and purpose-driven environment.
QA Specialist employer: Hyper Recruitment Solutions LTD
Contact Detail:
Hyper Recruitment Solutions LTD Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Specialist
✨Tip Number 1
Familiarise yourself with the specific regulations and guidelines related to GMP, HTA, FDA, and UK/EU standards. This knowledge will not only help you in interviews but also demonstrate your commitment to quality assurance in biopharmaceuticals.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, especially those working in QA roles. Attend relevant conferences or webinars to connect with potential colleagues and learn more about the latest trends and challenges in quality assurance.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that highlight your skills in deviation management, CAPA processes, and documentation control. Being able to articulate these experiences clearly can set you apart during the interview process.
✨Tip Number 4
Research the company’s recent projects and initiatives in cell and gene therapy. Showing that you understand their work and how you can contribute to their goals will make a strong impression during your discussions with them.
We think you need these skills to ace QA Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, GMP functions, and any specific projects related to biopharmaceuticals or cell and gene therapies. Use keywords from the job description to align your skills with what the company is looking for.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for quality assurance in the biopharmaceutical sector. Mention specific experiences that relate to the key duties and responsibilities listed in the job description.
Highlight Relevant Qualifications: Clearly state your degree and any additional certifications related to Quality Assurance or Pharmaceutical Chemistry. If you have experience with regulations like HTA, FDA, or UK/EU standards, make sure to include that as well.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a role in Quality Assurance.
How to prepare for a job interview at Hyper Recruitment Solutions LTD
✨Know Your GMP Regulations
Familiarise yourself with Good Manufacturing Practice (GMP) regulations, as they are crucial in the biopharmaceutical industry. Be prepared to discuss how your experience aligns with these standards and any specific examples of compliance you've managed.
✨Highlight Relevant Experience
Make sure to emphasise your previous roles in Quality Assurance, Quality Control, or Production within GMP-regulated environments. Share specific instances where you successfully handled deviations, CAPA processes, or documentation control.
✨Understand the Pharmaceutical Quality System
Demonstrate your knowledge of the Pharmaceutical Quality System (PQS) and its components. Be ready to explain how you have contributed to maintaining oversight of PQS in past roles, including your approach to issue management and change control.
✨Prepare Questions About the Role
Show your interest in the position by preparing thoughtful questions about the company's quality culture and the specific projects you might be involved in. This not only demonstrates your enthusiasm but also helps you assess if the role is the right fit for you.
