At a Glance
- Tasks: Support the Quality Department in maintaining the Quality Management System and ensuring compliance.
- Company: Join RoslinCT, a pioneering company in cell and gene therapies that changes lives.
- Benefits: Generous salary, 31 days annual leave, private healthcare, and flexible benefits.
- Other info: Inclusive workplace with excellent career development opportunities.
- Why this job: Be part of a rapidly expanding company making a real impact in healthcare.
- Qualifications: Degree in Life Sciences and experience in a GMP environment required.
The predicted salary is between 28800 - 48000 £ per year.
RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies. It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep. RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.
Location: Edinburgh BioQuarter/Shawfair
Who are we?
We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.
Why join us?
- The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
- A generous salary package – we reward our people at the level they deserve.
- 31 days of annual leave, plus 4 public holidays which increases with tenure.
- A competitive company pension scheme to help you save for the future.
- Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
- Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
- Flexible benefits such as retail discounts and access to the Cycle2Work scheme.
Your new role
An exciting opportunity for a Quality Assurance Officer to join our Quality team. Your primary role will be to support the Quality Department with all activities related to maintenance of the Quality Management System.
- Reviewing Standard Operating Procedures (SOPs) to ensure compliance with company policies, practices and relevant standards and guidelines.
- Writing SOPs and updating SOPs for QA activities.
- Administering, reviewing and approving Incident Reports, Change Controls and Risk Assessments.
- Performing data review audits (Batch Production Records, Validation Documents and Development Documentation as required).
- Performing internal audits to determine compliance with GMP and identify areas for improvement.
- Issuing, reviewing and closing Corrective and Preventative Actions (CA/PAs).
- Reviewing and approving suppliers / service providers including supporting with audits of critical suppliers where required.
About you
- Experience in a similar role within a relevant industry (e.g. pharmaceutical industry / stem cell activities).
- Previous experience in a GMP environment.
- A clear understanding of GMP, regulatory and accreditation systems and quality management.
- Proven experience in the maintenance of an electronic Quality Management System.
- Have excellent influencing, communication, interpersonal and motivational skills.
- An ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.
- Competent in computer packages including Microsoft Office and an electronic quality management package.
- The candidate must be able to multitask, have excellent attention to detail and time management skills.
- Excellent administration and record keeping skills.
Qualifications
Educated to degree level in a Life Sciences discipline.
Next Steps
If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you. At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners. We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms. If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us. We’re here to assist and make things as smooth as possible for you.
Quality Assurance Officer - QMS in Edinburgh employer: RoslinCT
At RoslinCT, we pride ourselves on being a pioneering employer in the field of cell and gene therapy, located in the vibrant Edinburgh BioQuarter. Our collaborative work culture fosters innovation and personal growth, offering extensive career development opportunities alongside a generous benefits package that includes 31 days of annual leave, private healthcare, and a competitive pension scheme. Join us to be part of a mission-driven team dedicated to creating life-changing therapies while enjoying a supportive and inclusive workplace.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Officer - QMS in Edinburgh
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching RoslinCT and understanding their work in cell and gene therapies. Tailor your answers to show how your skills align with their mission and values.
✨Tip Number 3
Practice common interview questions and scenarios related to Quality Assurance. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your experience effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining our team at RoslinCT.
We think you need these skills to ace Quality Assurance Officer - QMS in Edinburgh
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance Officer role. Highlight relevant experience in quality management systems and GMP environments, as this will show us you’re a great fit for the position.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how your skills align with our mission at RoslinCT. We love seeing genuine enthusiasm!
Be Clear and Concise:When filling out the application form, keep your answers clear and to the point. We appreciate straightforwardness, so make sure to highlight your key achievements and experiences without rambling.
Showcase Your Soft Skills:Don’t forget to mention your interpersonal and communication skills! As a Quality Assurance Officer, you’ll need to work collaboratively, so let us know how you’ve successfully influenced and motivated others in your previous roles.
How to prepare for a job interview at RoslinCT
✨Know Your GMP Inside Out
Since the role is heavily focused on Good Manufacturing Practices (GMP), make sure you brush up on your knowledge of GMP regulations and how they apply to quality management systems. Be ready to discuss specific examples from your past experience where you've ensured compliance or improved processes.
✨Showcase Your SOP Skills
As a Quality Assurance Officer, you'll be reviewing and writing Standard Operating Procedures (SOPs). Prepare to talk about your experience with SOPs in detail. Bring examples of SOPs you've created or updated, and be ready to explain how you ensured they met company policies and regulatory standards.
✨Demonstrate Your Analytical Thinking
This role requires strong analytical skills for tasks like data review audits and risk assessments. Think of instances where you've had to analyse complex information and make decisions based on that data. Be prepared to share these experiences and how they led to improvements in quality management.
✨Communicate Effectively
Excellent communication and interpersonal skills are key for this position. Practice articulating your thoughts clearly and confidently. You might be asked to explain technical concepts, so think about how you can simplify complex ideas for different audiences, showcasing your ability to influence and motivate others.
