Quality Assurance Officer II Location: 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. Find out more about what we do here ! 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 II to join our Quality team. You’ll be responsible for: Management and approval of artwork. Conducting internal audits to verify GMP compliance and identify areas for improvement. Assisting QA management with customer audits and regulatory inspections. Writing, reviewing and updating Standard Operating Procedures (SOPs) to ensure alignment with company policies, current practices, and applicable regulatory standards and guidelines. Evaluating and approving suppliers and service providers, supporting audits of critical suppliers when necessary. Delivering training on quality related topics to employees across RoslinCT. Compiling quality metrics to facilitate monitoring of the RoslinCT Quality Management System (QMS). Review and approval of quality documentation, including Deviations, Change Controls and Risk Assessments. Reviewing data to verify GMP compliance and identify areas for improvement. About you Comprehensive understanding of cGMP principles. Proficient in computer systems, including Microsoft Office and electronic quality management systems. Strong verbal communication skills, demonstrating confidence when engaging with team members, RoslinCT employees and clients. Excellent written communication skills, with the capability of recording and reporting data clearly, concisely and in compliance with documented procedures. Sound decision-making skills, balancing customer needs with compliance requirements and exercising sound judgement in challenging situations. Proactive in driving continuous improvement, contributing to the enhancement of quality systems and practices. Flexible and adaptable, able to respond positively to both immediate priorities and longer-term planned workloads. Self-motivated and reliable, demonstrating the ability to work effectively with minimal supervision. Qualifications Degree in a Life Science, or related subject or at least 2 years’ minimum industry experience. 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 at jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.