Quality Investigator I at RoslinCT

City of Edinburgh, Scotland, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

20 Aug, 26

Salary

0.0

Posted On

22 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, Root Cause Analysis, FMEA, Technical Writing, Aseptic Processing, Quality Management, Sterile Manufacture, Microsoft Office, Documentation Management, Stakeholder Management, Regulatory Compliance, Lean Six Sigma

Industry

Biotechnology Research

Description

Quality Investigator I 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 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 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. 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.

Responsibilities

Perform detailed investigations of non-compliances and technical deviations within a cGMP environment. Lead Root Cause Analysis events and collaborate with departments to implement CAPAs and ensure timely closure of quality management tasks.