Quality Investigator I

**Quality Investigator I** **Location**: Edinburgh bioQuarter **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** - We are looking for a **Quality Investigator I **to join our team - Support the Manufacturing Department with all activities related to maintenance of the Quality Management System. - Provide technical leadership of manufacturing projects and act as the technical point of contact for the client where applicable. - You will be responsible for performing detailed and thorough investigations of non-compliances by closure date including product impact assessment, systematic root cause analysis, and identification of effectual corrective and preventative actions. - Conduct and summarise technical deviation/incident investigations, translating complex operational events into understandable and cohesive summary reports. - Analyse each event and assess impact in the context of the sterile medicines’ cGMP regulations. - Gather data from across the organisation, lead and perform root cause analysis to determine the most likely cause. - Identify realistic by effectual corrective and preventative actions. - Plan, execute, and lead RCA events with attendance from relevant departments. - Work closely and collaboratively with operational departments to identify appropriate actions and facilitate deviation closure. - Present technical status updates of RCA and findings to RoslinCT management, customers, customer auditors, and regulatory inspectors. - Train and coach relevant operational personnel to develop their technical writing and investigation skills. **About you** - Experience of working in an aseptic sterile manufacturing environment or supporting function. - Experience of cGMP regulations particularly in respect of aseptic processing, documentation, and record management. - Experience of cell culture methods and techniques. - Background of technical RCA and FMEA techniques. - Working knowledge of PICS and ISO regulations. - Experience with technical writing. - Excellent communication and interpersonal skills and the ability to build effective relationships with a variety of stakeholders. - A good working knowledge of Microsoft Office. - Ability to handle multiple priorities in a very dynamic environment. - Excellent attention to detail and administration and record keeping skills. - Exceptional organisational and planning skills with a "can do attitude”. **Next Steps** - 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._