At a Glance
- Tasks: Ensure quality standards in a clinical manufacturing environment and support facility expansion projects.
- Company: Join a leading organisation focused on innovative biologics and cellular therapies.
- Benefits: Competitive salary, professional development opportunities, and a collaborative work culture.
- Other info: Located in Stevenage, this is a 12-month fixed-term contract role.
- Why this job: Be part of impactful projects that enhance healthcare while working with a dynamic team.
- Qualifications: Degree in life sciences and 5-10 years of QA experience in a clinical setting required.
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.
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. 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 ATMPs 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 prioritise 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.
- 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: Jas Gujral
Join a forward-thinking technology company that values innovation and collaboration, offering a dynamic work culture where your contributions truly matter. With flexible working arrangements and opportunities for professional growth, particularly in cutting-edge areas like Azure and DevOps, this role in Victoria London provides a unique chance to work on impactful projects alongside talented professionals. Embrace the opportunity to advance your career in a supportive environment that prioritises employee development and well-being.
StudySmarter Expert Advice🤫
We think this is how you could land QA Specialist with GMP in Stevenage
✨Tip Number 1
Familiarise yourself with the specific regulatory environments mentioned in the job description, such as EMA and FDA. Understanding these regulations will not only help you during interviews but also demonstrate your commitment to quality assurance in a clinical setting.
✨Tip Number 2
Network with professionals in the QA field, especially those who have experience in biologics or ATMPs. Engaging with industry peers can provide insights into the role and may even lead to referrals, increasing your chances of landing the job.
✨Tip Number 3
Prepare to discuss your experience with multidisciplinary project teams and how you've contributed to facility qualifications or cleanroom activities. Be ready to share specific examples that highlight your ability to manage multiple tasks while maintaining attention to detail.
✨Tip Number 4
Showcase your interpersonal skills by preparing to discuss how you've built rapport and trust with colleagues across different departments. This is crucial for a role that requires collaboration and effective communication within a multi-disciplinary team.
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 highlights your relevant experience in quality assurance, particularly within a clinical environment. Emphasise your expertise in GMP, sterile manufacturing processes, and any specific projects you've worked on that align with the job description.
Craft a Compelling Cover Letter:Write a cover letter that directly addresses the key responsibilities and skills mentioned in the job description. Use specific examples from your past experience to demonstrate how you meet the requirements, especially your knowledge of EMA and FDA regulations.
Highlight Interpersonal Skills:Since the role requires excellent communication and teamwork, make sure to include examples of how you've successfully collaborated with multidisciplinary teams. Mention any instances where you've built rapport and trust with colleagues across different departments.
Proofread Your Application:Before submitting your application, thoroughly proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a QA Specialist role.
How to prepare for a job interview at Jas Gujral
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of EMA and FDA regulations during the interview. Prepare specific examples of how you've navigated these environments in past roles, as this will demonstrate your expertise and readiness for the position.
✨Emphasise Team Collaboration
Since the role involves working within a multi-disciplinary team, be ready to discuss your experience in collaborative projects. Share instances where you successfully engaged with colleagues from different departments to achieve common goals.
✨Demonstrate Attention to Detail
Quality Assurance requires a keen eye for detail. Prepare to discuss how you manage multiple tasks while maintaining high standards. You could mention specific tools or methods you use to ensure accuracy and compliance in your work.
✨Prepare for Compliance Scenarios
Anticipate questions related to compliance issues and how you've handled them in the past. Think of examples where you provided pragmatic GMP advice or facilitated the escalation of compliance concerns, as this will showcase your problem-solving skills.
