Quality Investigator

3 months ago

Edinburgh, United Kingdom RoslinCT Full time

**Quality Investigator**

**Location**: Edinburgh BioQuarter, Little France

**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 **to join our team.
- You will be responsible for performing detailed and thorough investigations of non-compliances by closure date including product impact assessment, systematic root cause analysis, and identification of effectual corrective and preventative actions.
- Conduct and summarise technical deviation/incident investigations, translating complex operational events into understandable and cohesive summary reports.
- Analyse each event and assess impact in the context of the sterile medicines cGMP regulations.
- Gather data from across the organisation, lead and perform root cause analysis to determine the most likely cause.
- Identify realistic by effectual corrective and preventative actions.
- Perform ‘in the field’ investigations, collecting data and interviewing involved personnel.
- Ensure timely completion and closure of deviations and investigations.
- Plan, execute, and lead RCA events with attendance from relevant departments.
- Work closely and collaboratively with operational departments to identify appropriate actions and facilitate deviation closure.
- Present technical status updates of RCA and findings to RoslinCT management, customers, customer auditors, and regulatory inspectors.
- Train and coach relevant operational personnel to develop their technical writing and investigation skills.
- Partner with Lead Biotechnologists/Scientists, Supervisors, and Trainers to conduct sharing sessions with operators on investigation outcomes, impacts, and CAPAs.
- Evaluate trends and work proactively and collaboratively on targeted initiatives to reduce deviations. Input into other quality management work such as Change Controls, Risk Assessments, FMEA, document updates and CAPA implementation.

**About you**
- Experience of cell culture methods and techniques.
- Experience of working in an aseptic sterile manufacturing environment or supporting function.
- Excellent working knowledge of cGMP regulations particularly in respect of aseptic processing, contamination control, documentation, and record management.
- Working knowledge of PICS and ISO regulations.
- Experience with technical writing.
- Background of technical RCA and FMEA techniques.
- You will have excellent communication and interpersonal skills and the ability to build effective relationships with a variety of stakeholders.
- Ability to handle multiple priorities in a very dynamic environment.
- You must have a good working knowledge of Microsoft Office.
- Excellent attention to detail and administration and record keeping skills.
- Ability to learn and share knowledge with the management team and the wider team where appropriate.

**Next Steps**
- 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 encourage to be themselves, whether they’re our employees, customers, or partners._

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