puestos de Quality Assurance Analyst en United States

Senior QC Analyst – Analytical

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 for a Senior QC Analyst – Analytical to join our Quality team.
• You’ll be responsible for working with the development team on analytical assays for testing human embryonic stem cell lines and cell & gene therapies for human application.
• Identify area of improvement and lead process improvement projects within the department.
• Perform assimilation, statistical analysis, and interpretation of complex, multi-format data sets.
• Author, revise, and implement QC SOPs in alignment with regulatory guidelines.
• Lead root cause investigations into contamination events and deviations.
• Compile and report on analytical data to facilitate product release.
• Develop and deliver trend analyses and periodic summary reports for senior management, including QPs, and chair formal review meetings to drive data-driven improvements.
• Execute GMP documentation workflows within QC, including Incident Reports, Change Controls and Risk Assessments.
• Coordinate and perform QC batch release testing of advanced cellular therapy product
• Oversee day-to-day laboratory operations, ensuring adherence to cGMP, maintenance of QC systems, and operational excellence.

About you

• Prior experience working in a GMP Quality Control molecular biology / analytical laboratory, with commercial experience.
• Experience in assay validation, stability testing, tissue culture, QC product testing and writing procedures to meet GMP and ICH guidelines.
• Experience in a variety of laboratory activities, with specialist knowledge of Flow Cytometry.
• Working knowledge of UK laws and regulations for cell therapy products and tissue donation.
• Excellent verbal communication skills, with the ability to effectively manage and influence stakeholders’ and customer expectations.
• Exceptional written communication skills, with a good standard of written English to support writing reports accurately and clearly.
• Good organisational and planning skills with the ability to multi-task in a fast-paced environment.

Qualifications

• A degree in a life science, or relevant subject. A postgraduate qualification 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.