Quality Investigator Ii

6 months ago

Edinburgh, United Kingdom RoslinCT Full time

**Quality Investigator II**

**Location**: NINE, 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 recruiting for a **Quality Investigator II** to join our team as part of our continued growth and success.
- Conduct and summarise technical deviations, translating complex operational events into understandable and cohesive summary reports. This includes ‘in the field’ investigations, collecting data, and interviewing involved personnel.
- Analyse each deviation and assess the impact in the context of the sterile medicines’ cGMP regulations.
- Gather data from across the organisation, lead, and perform systematic Root Cause Analysis (RCA) to determine most likely cause. Input RCA data into key performance indicator (KPI) trackers.
- Identify realistic but effectual Risk Assessments, Corrective and Preventative Actions (CAPAs) and/or Change Controls by partnering with the relevant departments.
- Input into other Quality Management work such as Manufacturing Batch review and document updates where required.
- Support the review and approving of Quality Management work (where required).
- Ensure the timely completion and closure of Quality Management work by working collaboratively with relevant departments.
- Conduct ad-hoc self-inspections GEMBA walkabouts of RoslinCT cleanrooms to determine compliance with GMP and identify areas for improvement.
- Compile quality metrics and evaluate trends in deviation root cause and CAPA effectiveness.
- Present data to manufacturing management (including Qualified Person), customers and regulatory inspectors to highlight performance deficiencies and ensure lessons learned are communicated and developed in improvement initiatives. Assist in training and coaching relevant personnel to develop their technical writing and investigative skills.

**About you**
- Minimum 3-5 years’ experience in Sterile Manufacture - and/or Quality-related role.
- Experience in stem cells, gene/cellular therapies, or cell banking.
- Experience with following standard operating procedures and using technical RCA and FMEA techniques.
- Experience of cGMP regulations particularly in respect of aseptic processing, documentation, and record management.
- You will have a working knowledge of MHRA, FDA, EMA, PICS, and ISO regulations.
- Demonstrable competence in reporting and presenting internally/externally (e.g. MHRA visits, customer visits, training, auditing).
- Excellent Microsoft Office skills and experience in an electronic quality management package.
- You will have excellent written and verbal communication skills with the ability to partner with all levels of RoslinCT.
- Excellent organisational skills with the ability to multi-task in a fast-paced and dynamic environment.

**Qualifications**
- Yellow Belt certification in Lean Six Sigma tools is desirable.

**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 encouraged to be themselves, whether they’re our employees, customers, or partners._

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