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
* An exciting opportunity to join our Manufacturing team as a Quality Investigator II.
* A key role which will lead technical support and quality oversight for manufacturing, ensuring compliance, effective investigations, and robust quality systems.
* Conduct and summarise technical deviations, translating complex operational events into cohesive summary reports.
* Analyse each deviation to assess impact in the context of cGMP regulations.
* Lead and perform systematic Root Cause Analysis.
* Identify Risk Assessments, Corrective and Preventative Actions and/or Change Controls.
* Support the reviewal and approval of Quality Management work when required.
* Conduct ad-hoc self-inspections of the cleanrooms to ensure compliance with GMP regulations are met.
* Compile and present quality metrics and trends in Deviation root cause and CAPA effectiveness.
* Assist in the training and coaching of relevant personnel.
* Attending and representing in OQIT meetings to provide feedback on quality management documents.
About you
* Minimum 3-5 years’ experience in Sterile Manufacture and/or Quality-related role.
* Prior experience in stem cells, gene/cellular therapies or cell banking.
* Working experience with following standard operating procedures and using technical RCA & FMEA techniques.
* Experience of cGMP regulations, particularly in aseptic processing, documentation and record management.
* Working knowledge of MHRA, FDA, EMA, PICS and ISO regulations.
* Technical writing experience – demonstrating competence in reporting and presenting internally and externally.
* Possess leadership qualities, with a desire to continually develop and improve processes.
* Strong computer skills with experience in Microsoft Office - ideally, you will also have experience in an electronic quality management package.
Qualifications
* Life Science degree or equivalent qualification / experience.
* Yellow Belt certification in Lean Six Sigma tools is desirable.
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.
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