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, experience with regulatory compliance, and a degree in life sciences.
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 employer: Onyx-Conseil
Our Client is an exceptional employer, offering a collaborative and innovative work culture that prioritises quality and compliance in the biopharmaceutical sector. Located in Stevenage, Hertfordshire, employees benefit from a supportive environment that fosters professional growth through multidisciplinary teamwork and engagement with regulatory authorities. With competitive salaries and a commitment to evolving quality standards, this role provides a meaningful opportunity to contribute to cutting-edge projects in a dynamic industry.
StudySmarter Expert Advice🤫
We think this is how you could land QA Specialist with GMP
✨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 or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and regulatory standards. We recommend practising common interview questions and scenarios specific to QA roles, so you can showcase your expertise confidently.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace QA Specialist with GMP
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 up with 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) guidelines and how they apply to the role. Be ready to discuss your experience with regulatory environments like EMA and FDA, as well as any specific projects you've worked on that relate to sterile manufacturing processes.
✨Showcase Your Team Spirit
This role involves working within a multi-disciplinary team, so be prepared to share examples of how you've successfully collaborated with others in past projects. Highlight your ability to engage constructively with colleagues at all levels and how you’ve contributed to a positive quality culture.
✨Prepare for Compliance Questions
Expect questions about compliance and quality assurance. Think of scenarios where you had to provide pragmatic GMP advice or escalate compliance issues. Being able to articulate these experiences will show your expertise and confidence in handling quality interactions.
✨Demonstrate Your Organisational Skills
With multiple tasks on the go, it’s crucial to showcase your ability to prioritise effectively. Prepare to discuss how you manage your workload, maintain attention to detail, and ensure that all quality standards are met consistently across different projects.
