RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies.
It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep.
RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.
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 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 ****** .
We're here to assist and make things as smooth as possible for you.