At a Glance
- Tasks: Ensure quality standards in a clinical environment and support facility expansion projects.
- Company: Leading biotech firm focused on innovative therapies and quality assurance.
- Benefits: Competitive salary, professional development, and a collaborative work culture.
- Other info: Opportunity for career growth in a fast-paced, multi-disciplinary environment.
- Why this job: Join a dynamic team and make a real impact in the biotech industry.
- Qualifications: 5-10 years in QA, knowledge of GMP, and strong communication skills.
The predicted salary is between 45000 - 50000 £ per year.
Our Client is looking to recruit a QA Specialist with at least 5 to 10 years expertise within a clinical environment. Reporting to and with the guidance of the Head of Quality Assurance, this role will ensure that the manufacturing centre, via proactive engagement, meets the standards and expectations of two key stakeholders; the regulatory authorities and potential collaborators.
To work within a multi-disciplinary team to take a tactical role in the governance and oversight of the activity associated with delivering beneficial use to the facility expansion. To act as a single point of contact for all Quality interactions between the manufacturing centre and third-party contractors responsible for delivering the expansion.
Participate in the preparation for and the management of regulatory agency and client inspections related to the expansion project. Ensure the PQS is maintained in a fit for purpose state of control for a multi-purpose, multi-client facility and ensure consistency between existing processes and procedures and those associated with the extension.
Provide general quality subject matter expertise to the expansion project team. Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes. Promote the awareness of quality requirements and support the evolution of the quality culture throughout the company.
Experience must include the following skills:
- Participation in multidisciplinary project teams with experience in facility and/or cleanroom qualification activity and in sterile manufacturing processes, ideally ATMP’s or biologics.
- Sound knowledge of EMA and FDA regulatory environments and requirements.
- Familiar with global standards related to quality e.g. ISO 9001.
- Experience working as a Quality Specialist or equivalent in biologics and preferably cellular and/or gene therapies.
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
- Comfortable operating autonomously once goals and objectives are set.
- Excellent interpersonal, written and verbal communication skills.
- Confidence and ambition to provide pragmatic and considered GMP advice.
- Having current and up to date professional knowledge, expertise and best practice.
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
- Ability to quickly establish credibility and build rapport and trust.
- A good team player, with strong organisational skills.
- Educated to Degree level in a life sciences discipline.
- Member of a professional organisation e.g. RSC, SOB, CQI etc. (Desirable).
The Client is based in Stevenage Hertfordshire. The salary for this position is in the range £45K - £50K. Please send your CV to us in Word format along with your salary and availability.
QA Specialist with GMP in Stevenage employer: Onyx-Conseil
Our Client is an exceptional employer, offering a collaborative work culture that prioritises quality and compliance in the dynamic field of biologics. Located in Stevenage, Hertfordshire, employees benefit from a supportive environment that fosters professional growth through multidisciplinary teamwork and engagement with regulatory authorities. With a focus on innovation and excellence, this role provides a unique opportunity to contribute to meaningful projects while advancing your career in a thriving industry.
StudySmarter Expert Advice🤫
We think this is how you could land QA Specialist with GMP in Stevenage
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in quality assurance or related fields. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and regulatory standards. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Don’t just wait for job alerts! Actively search for QA Specialist roles on our website and apply directly. The more applications you send out, the better your chances of landing that dream job.
✨Tip Number 4
Follow up after interviews with a thank-you email. It’s a simple gesture that shows your enthusiasm for the role and keeps you fresh in the interviewer's mind. Plus, it’s a great way to reiterate your fit for the position!
We think you need these skills to ace QA Specialist with GMP in Stevenage
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the QA Specialist role. Highlight your experience in clinical environments and any relevant projects you've worked on. We want to see how your skills match what we're looking for!
Showcase Your Expertise:Don’t hold back on showcasing your knowledge of GMP, EMA, and FDA regulations. We’re keen to see how you can bring your expertise to our team, so make it clear in your application!
Be Clear and Concise:When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read through your qualifications and experiences. We appreciate a well-structured application!
Apply Through Our Website:Remember to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Onyx-Conseil
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practice (GMP) regulations and guidelines. Be ready to discuss how your experience aligns with these standards, especially in relation to biologics and ATMPs. This will show that you’re not just familiar with the rules but can apply them effectively.
✨Showcase Your Teamwork Skills
Since this role involves working within a multi-disciplinary team, prepare examples of how you've successfully collaborated with others in past projects. Highlight your ability to engage constructively with colleagues at all levels, as this will demonstrate your fit for the company culture.
✨Prepare for Regulatory Questions
Expect questions about your knowledge of EMA and FDA regulatory environments. Brush up on recent changes or updates in these areas, and be prepared to discuss how you’ve navigated compliance issues in previous roles. This will show that you’re proactive and knowledgeable.
✨Communicate Clearly and Confidently
Your verbal and written communication skills are crucial for this position. Practice articulating your thoughts clearly and confidently, especially when discussing complex quality assurance topics. This will help you establish credibility and build rapport during the interview.
