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 Assurance Supervisor 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 Assurance Supervisor to join our team!
As the RoslinCT QA Shift Supervisor, the primary function is to support the Quality Operations Manager helping to develop, manage and coordinate the Quality Assurance requirements of the company.
This position will predominantly be Monday-Friday 9am-5pm but will include some evening and weekend work from time-to-time.
Maintain an effective Quality Management System (QMS) which ensures compliance with the necessary legislation (e.g.
Human Tissue Act Scotland 2006, EU Directives (2004/23/EC, Human Tissue (Quality and Safety for Human Application) Regulations 2007, Human Medicines Regulation 2012 (SI 2012/1916), ATMP Directive 2001/83/EC, GMP Directive 2004/93/EC and ISO 9001:2015.
Ensure that clinical stem cell lines and ATMPs produced by RoslinCT fully comply with the requirements of Good Manufacturing Practice (GMP) and research and development activities meet the appropriate standard of ISO9001:2015.
Contribute to the development and continual maintenance of staff awareness in critical areas such as GMP, ISO: 9001:2015 and Quality Management Systems.
Support the QA Manager to maintain and continually improve RoslinCT Quality Management Systems (QMS) and ensure that these are fully compliant with the UK and EU regulations and legislation for stem cell lines and cellular therapies.
Particular attention to ensuring compliance with the applicable regulations (MHRA, HTA and FDA).
Develop and continually improve the awareness of RoslinCT staff in the requirements of GMP and best practice for applying GMP to RoslinCT activities.
Partner with the Manufacturing Team, providing real-time support and advice within the clean room during manufacturing.
Support with reviewing and approving the procedures relating to all RoslinCT activities to ensure their compliance with the relevant standard/guidelines.
Ensure that the training required within each department, as determined by department managers, is carried out and recorded.
Support in developing and delivering training in all aspects of Quality Management and GMP.
Support with ensuring systems are in place and followed for the reporting and investigation of quality related incidents, defective products or adverse events.
These systems will identify the root cause of such incidents and generate strategies for preventative actions.
Ensure systems are in place for the control of critical documents (e.g.
SOPs, policies) and records (e.g.
batch production records) to ensure they are reviewed regularly to reflect current processes, and they are available at the point of use.
Support with Risk Management Procedures and ensure risk assessments are performed across all aspects of the GMP activities.
Ensure that department equipment and processes used in the manufacture, storage and distribution of products are subject to effective validation and that documentation used in validations are approved.
About you A clear understanding of GMP, regulatory and accreditation systems and quality management.
Excellent leadership with the management skills and confidence to inspire others to achieve.
Demonstrable ability to take decisions, to analyse information in a logical manner with the ability to simplify and clearly present complex information.
Demonstrable competence in reporting and presenting internally/externally (MHRA visits, customer visits, training, auditing).
Effective communicator with the understanding of the dynamics around relationships and a proven track record in effective relationships management Competency in computer packages including Microsoft Office and QPulse.
Delivers excellent customer service.
Exceptional organisational and planning skills with the ability to plan whilst delivering results to deadline.
Excellent communication and interpersonal skills and a proven track record in negotiation whilst maintaining effective relationships.
Qualifications An Honours degree in a relevant life science or equivalent qualification.
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.
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.