Quality Investigator II

<p><strong>Quality Investigator II</strong></p><p><strong>Location:&nbsp;</strong>Edinburgh BioQuarter</p><p><strong>Who are we?</strong></p><p>We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.</p><p>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.</p><p>Find out more about what we do&nbsp;<a target="_blank" href="https://www.youtube.com/watch?v=x_E5injtzb0"><strong>here</strong></a>!</p><p><strong>Why join us?</strong></p><ul><li><p>The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.</p></li><li><p>A generous salary package – we reward our people at the level they deserve.</p></li><li><p>31 days of annual leave, plus 4 public holidays which increases with tenure.</p></li><li><p>A competitive company pension scheme to help you save for the future.</p></li><li><p>Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.</p></li><li><p>Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.</p></li><li><p>Flexible benefits such as retail discounts and access to the Cycle2Work scheme.</p></li></ul><p><strong>Your new role</strong></p><ul><li><p>An exciting opportunity for a&nbsp;<strong>Quality Investigator II </strong>to join our <strong>Quality Investigations</strong> <strong>Team</strong> (QIT).</p></li><li><p>You’ll be responsible for performing detailed and thorough investigations of non-compliances by closure date including product impact and/or risk assessment, systematic RCA and identification of CAPA’s and/or CC’s, by gathering data from across the organisation.</p></li><li><p>Provide oversight for the development and maintenance of quality programmes, systems, processes and procedures, ensuring compliance with internal policies and internal/external standards and guidelines.</p></li><li><p>Conduct ad-hoc self-inspections/GEMBA walkabouts of RoslinCT cleanrooms and laboratories to determine compliance with GMP and identify areas for improvement.</p></li><li><p>Compile quality metrics and evaluate trends in deviation root cause and CAPA effectiveness and present this data to Department Management, Customers and Regulatory Inspectors with a view to develop improvement initiatives.</p></li><li><p>Assist in training and coaching relevant personnel to support with technical writing and investigative skills.</p></li><li><p>Work closely with relevant departments to ensure timely completion and closure of Quality Management work in accordance with SOP timelines.</p></li><li><p>Attend QIT meetings and represent QIT at meetings to provide appropriate feedback in respect status and progression of quality management documents.</p></li></ul><p><strong>About you</strong></p><ul><li><p>Proven experience working in a GMP regulated environment, particularly in aseptic processing, documentation and record management.<span>&nbsp;</span></p></li><li><p>Background in stem cells, gene/cellular therapies or cell banking.</p></li><li><p>Experience with following SOP’s and using technical RCA and FMEA techniques.<span>&nbsp;</span></p></li><li><p>Working knowledge of MHRA, FDA, EMA PICS and ISO regulations.</p></li><li><p>Strong technical writing skills, with competence in reporting and presenting internally/externally.</p></li><li><p>Demonstrated leadership qualities, communication, interpersonal and motivational skills.</p></li><li><p>Proficient in Microsoft Office, and ideally an electronic quality management package.</p></li></ul><p><strong>Qualifications</strong></p><ul><li><p>A degree in a Life Science subject, or equivalent qualification/experience.</p></li><li><p>Minimum 3-5 years’ experience in Sterile Manufacture and/or Quality-related role.</p></li><li><p>Yellow Belt certification in Lean Six Sigma is desirable.</p></li></ul><p><strong>Next Steps</strong></p><p>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.</p><p><em>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.</em></p><p><em>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.</em></p><p><em>If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at&nbsp;</em><a target="_blank" href="mailto:[email protected]"><em>[email protected]</em></a><em>. We’re here to assist and make things as smooth as possible for you.</em></p><p>&nbsp;</p>