Quality Investigator I

RoslinCT; City of Edinburgh; Presencial; GBP 28.000 - 38.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Generous salary package

31 days annual leave + public holidays

Group Life Cover

Private healthcare

Cycle2Work scheme

Pension scheme

Flexible benefits

Descripción de la vacante

RoslinCT, a leading cell and gene therapy CDMO, is seeking a Quality Investigator I in Edinburgh BioQuarter. You will investigate non-conformances, conduct deviation investigations, and translate complex events into concise reports, including field investigations in QC labs or clean rooms.

Applicants should have GMP experience, a life science background, and strong technical writing skills. The role involves cross-department collaboration and CAPA procedures.

Formación

• GMP-regulated environment and aseptic processing experience.
• Background in stem cells or gene/cellular therapies.
• Experience with SOPs and RCA/FMEA techniques.
• Knowledge of MHRA, PICS and ISO regulations.
• Strong technical writing and deviation/incident investigation experience.
• Proficiency in Microsoft Office; familiarity with electronic QMS.
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Responsabilidades

• Investigate non-compliances and close out investigations by the specified due date.
• Conduct deviation/incident investigations and translate complex events into clear summary reports (visits to QC labs or clean rooms as needed).
• Analyze deviations for impact under sterile medicines cGMP regulations.
• Plan, execute, and lead RCA events with cross-department attendance.
• Collaborate with departments to ensure timely completion and closure of Quality Management work per SOP timelines.
• Share investigation outcomes and CAPAs with relevant personnel and trainers.
• Support daily QIT housekeeping tasks (filing, photocopying, transferring documents).

Conocimientos

GMP environment

Aseptic processing

Technical writing

MS Office

Educación

Life Science degree or equivalent

2 years sterile manufacture/quality experience

Herramientas

Electronic quality management system

Descripción del empleo

Quality Investigator I

Location: Edinburgh BioQuarter

Closing Date: COB Wednesday 18th November 2026

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 dohere!

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 Quality Investigator I to join our Quality Investigations Team (QIT).

• You’ll be responsible for performing detailed and thorough investigations of non-compliances by closure date.

• Conduct and summarise technical deviation / incident investigations, translating complex operational events into summary reports which may involve visiting Quality Control Laboratories or Manufacturing Clean Rooms as part of in the field investigations.

• Analyse deviations and assess impact in the context of the sterile medicines’ cGMP regulations.

• Plan, execute, and lead RCA events with attendance from relevant departments.

• Work closely with relevant departments to ensure timely completion and closure of Quality Management work in accordance with SOP timelines.

• Collaborate with relevant Departmental Management and Trainers to conduct sharing sessions with personnel involved in deviation events on investigation outcomes, impacts and CAPAs.

• Support with daily QIT housekeeping activities, including but not limited to filing, photocopying and transferring documents to other RoslinCT sites.

About you

• Proven experience working in a GMP regulated environment, particularly in aseptic processing, documentation and record management.

• Background in stem cells, gene/cellular therapies or cell banking

• Experience with following SOP’s and using technical RCA and FMEA techniques.

• Working knowledge of MHRA, PICS and ISO regulations.

• Strong technical writing skills, with preferred experience in deviation/incident investigations and experience addressing GMP audit comments.

• Proficient in Microsoft Office, and ideally an electronic quality management package.

• Excellent attention to detail, with the ability to handle multiple tasks at a given time in a dynamic and changing environment.

• Exceptional written and verbal communication skills, building effective relationships with various stakeholders.

Qualifications

• A degree in a Life Science subject, or equivalent qualification/experience.

• Minimal 2 years’ experience in Sterile Manufacture and/or Quality related role.

• Yellow Belt Certification in Lean Six Sigma is desirable.

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 [e-mail]. We’re here to assist and make things as smooth as possible for you.