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

If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form.

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.