At a Glance
- Tasks: Support quality assurance in a dynamic pharmaceutical environment and engage in impactful projects.
- Company: Join a leading Cell and Gene Therapy Catapult with a mission to innovate healthcare.
- Benefits: Gain valuable experience, develop skills, and enjoy a collaborative work culture.
- Other info: Opportunities for personal growth and travel within a supportive team.
- Why this job: Be part of a cutting-edge industry and contribute to life-changing therapies.
- Qualifications: A-level science qualification; degree in life sciences is a plus.
The predicted salary is between 30000 - 40000 £ per year.
The Quality Assurance Associate will work within the QA team to support the operation and performance measurement of the Pharmaceutical Quality System (PQS) across the CGT Catapult MICs (Stevenage and Braintree), maintain documentation in all forms, support assessment of quality records, and provide training to personnel in core competencies.
Key Responsibilities
- Perform QA functions within the eQMS (MasterControl / Ideagen)
- Issue, review, and reconcile controlled documents to CGT Catapult departments and Collaborator organisations
- Maintain QMS trackers and generate trends and graphs for effective monitoring of the health of the QMS by System Owners and Management
- Engage with quality record owners to support right-first-time and on-time completion
- Support with Collaborator and external regulatory inspection preparation (e.g. MHRA), including participation in the inspection “backroom” to provide documentation and records under strict timelines during inspection
- Perform facility walkarounds, assessing compliance with established procedures
- Review basic quality documentation such as Non-Conformances, CAPAs, Change Controls, and procedure updates
- Support off-site archiving of departmental records (for example: logbooks, forms and reports)
- Support the delivery of GMP training to internal colleagues and Collaborator personnel
- Provide support to activities across the CGT Catapult MICs with attendance and periodic travel to the CGT Catapult
Experience
- Experience working in a GMP or Quality Assurance environment
- Experience in the use and operation of an electronic QMS is advantageous
- Experience in Biologics or ATMP, or Sterile manufacturing is advantageous
Skills, Knowledge and Expertise
- Highly motivated, pragmatic, and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UK
- Desire to establish a high-profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success
- High-level interpersonal, communication (oral and written) skills and emotional intelligence
- A good team player with a hands-on approach, and adaptable to new challenges
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs
- Flexibility towards work assignments and new learning
- Ambitious, collaborative, driven
- Accurate, with a strong attention to detail
- Planning and time management of tasks to ensure deadlines are consistently met, factoring in the potential of changing circumstances
- Communicates with clarity and conciseness, understanding and adapting the message to engage different audiences
- Retains an engaged and active mind through routine processes/procedures to remain alert to anomalies or situations requiring further thought/action
- A positive attitude towards learning, personal and professional development
- Keeps up to date with industry best practice
- Willingness to travel
Education / Qualifications
- A-level science qualification
- Degree in life sciences (advantageous)
Interim QA Associate (15 Month FTC) in Stevenage employer: Cell and Gene Therapy Catapult
At Cell and Gene Therapy Catapult, we pride ourselves on being an excellent employer that fosters a collaborative and innovative work culture in the heart of Fisher's Pond, England. Our commitment to employee growth is evident through continuous training opportunities and a supportive environment that encourages professional development, making it an ideal place for those passionate about advancing cutting-edge therapies.
Contact Details:
Cell and Gene Therapy Catapult Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Interim QA Associate (15 Month FTC) in Stevenage
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
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Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
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We think you need these skills to ace Interim QA Associate (15 Month FTC) in Stevenage
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Cell and Gene Therapy Catapult.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Cell and Gene Therapy Catapult. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Cell and Gene Therapy Catapult
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Cell and Gene Therapy Catapult.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Cell and Gene Therapy Catapult achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.