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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 a competitive salary, career growth opportunities, and a chance to work on impactful projects.
- Why this job: Influence quality culture in a purpose-driven environment while working on innovative clinical projects.
- Qualifications: A degree in a relevant scientific field 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.
14678Permanent Competitive Site Based South West – United Kingdom Updated on: 02-07-2025
We are currently looking for a Quality Assurance Specialist to join a leading biopharmaceutical services organisation based in the South West of the UK to join their team.
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
Your duties as the Quality Assurance Specialist will be varied however the key duties and responsibilities are as follows:
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
As the Quality Assurance Specialist you will 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
To be successful in your application to this exciting role as the Quality Assurance Specialist, we are looking to identify the following on your profile and past history:
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.
Key Words:
Quality Assurance Specialist / QA / GMP / PQS / Biopharmaceuticals / Cell and Gene Therapy / ATMP / Documentation / Validation / CAPA / CDMO / Regulated Environment / South West / Pharmaceutical QA
Hyper Recruitment Solutions Ltd (HRS)is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supportsSTEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Skills: Biological Sciences, QA/RA, Quality Assurance
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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 about the latest trends and challenges in quality assurance.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you successfully managed deviations or implemented CAPA processes. Being able to articulate these experiences will showcase your practical knowledge and problem-solving skills.
✨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 will set you apart from other candidates during the interview process.
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 knowledge of 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 Strong Cover Letter: Write a cover letter that not only introduces yourself but also explains why you are passionate about the role and how your background makes you a perfect fit. Mention specific experiences that relate to the key duties and responsibilities outlined in the job description.
Highlight Relevant Qualifications: Clearly state your degree and any additional qualifications related to Pharmaceutical Chemistry, Quality Assurance, or Quality Management. If you have experience with HTA, FDA, or UK/EU regulations, make sure to include that as well.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a Quality Assurance Specialist.
How to prepare for a job interview at Hyper Recruitment Solutions LTD
✨Know Your Regulations
Familiarise yourself with HTA, FDA, and UK/EU regulations. Being able to discuss these in detail will show your understanding of the compliance landscape in which the company operates.
✨Demonstrate Your Experience
Prepare specific examples from your past roles that highlight your experience in GMP functions, deviation management, and document control. This will help you illustrate your qualifications effectively.
✨Understand the PQS
Research the Pharmaceutical Quality System (PQS) and be ready to discuss how you can contribute to its oversight. Showing that you understand its importance will impress your interviewers.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality culture and ongoing projects. This demonstrates your genuine interest in the role and helps you assess if the company is the right fit for you.
