Quality Investigator Ii

**Quality Investigator II** **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 II **to join our team - You will perform detailed and thorough investigations of non-compliances by closure date including product impact, systematic root cause analysis, risk assessments, preventative actions, and more. - You will provide oversight for the development and maintenance of quality programmes, systems, processes and procedures that ensure compliance with our internal policies, as well as our internal/external standards and guidelines. - 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. - Analyse each deviation and assess the impact in the context of the sterile medicines’ cGMP regulations. - Gather data from across the organisation, lead and perform systematic Root Cause Analysis. - Support the reviewing and approving of Quality Management work, where required. - Conduct and summarise technical deviations, translating complex operational events into an understandable and cohesive summary reports. - Analyse each deviation and assess impact in the context of the sterile medicines’ cGMP regulations. **About you** - Experience in stem cells, gene/cellular therapies or cell banking. - Experience with following standard operating procedures and using technical RCA and FMEA techniques. - Experience of cGMP regulations particularly in respect of aseptic processing, documentation, and record management. - Working knowledge of MHRA, FDA, EMA, PICS and ISO regulations. - Experience with technical writing and demonstrable competence in reporting and presenting internally/externally (Regulatory visits, customer visits, training, auditing). - Demonstrable leadership qualities, communication, interpersonal and motivational skills. - Ability to work effectively within a small team. - Excellent attention to detail with a desire to continually develop and improve processes. - Exceptional organisational and planning skills with a "can do attitude”. - Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format to both technical and non-technical audiences. - Willingness to travel between RoslinCT sites and work extended hours as determined by the batch disposition schedule. **Qualifications** - Life Science degree or equivalent qualification/experience. - Minimum 3-5 years experience in Sterile Manufacture - and/or Quality-related role. - Yellow Belt certification in Lean Six Sigma tools is desirable. **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._