Quality Investigator Ii

1 week 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._

  • Quality Investigator

    2 weeks 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...

  • Quality Investigation Engineer

    2 months ago

    Edinburgh, United Kingdom Cpl Life Sciences Full time

    Stop the press!! Calling all Quality professionals who enjoy working across the full product lifecycle - from product concept through to manufacturing support. Within this Quality Investigation Engineer role you will have the opportunity to work with thequality systems, continuous improvement, verification/validation activities etc. **Role...

  • Quality Control Investigations Associate

    2 weeks ago

    Edinburgh, United Kingdom JPMorgan Chase & Co Full time

    **JOB DESCRIPTION** As a Quality Control Investigations Associate in the Financial Crime department, you will support the end to end review and completion of the SAR reporting process. A key element of the role is to create constructive feedback loops with the FCOI investigations team and wider stakeholders to achieve & improve overall the investigation...

  • Investigator

    3 weeks ago

    Edinburgh, United Kingdom Hays Specialist Recruitment Limited Full time

    Investigator required for public service body Your new company Role purpose You'll have responsibility for investigation and case management, reporting on, regulatory concerns raised. In your role you will gather and analyse information in order to assess whether someone is safe to practise and if they pose any risk. You will havean important role in making...

  • Investigator

    7 days ago

    Edinburgh, Edinburgh, United Kingdom Hays Specialist Recruitment Limited Full time

    Investigator required for public service bodyYour new companyRole purposeYou'll have responsibility for investigation and case management, reporting on, regulatory concerns raised. In your role you will gather and analyse information in order to assess whether someone is safe to practise and if they pose any risk. You will havean important role in making...

  • Investigator, External Investigative Reporting

    3 weeks ago

    Edinburgh, United Kingdom HSBC Full time

    Investigator, HUB External Investigative Reporting - Financial Crime Investigations - 12 MONTH SECONDMENT- GCB 6 REMOTE WORKING Discover a role that opens doors. If you’re looking for a career that will unlock new opportunities, join HSBC and experience the possibilities. Whether you want a career that could take you to the top or simply take you in an...

  • Investigator

    3 weeks ago

    Edinburgh, United Kingdom The Nursing and Midwifery Council Full time

    **Description**: **About the Team** The investigation team play an integral role in the Fitness to Practise process to ensure high quality and propionate decisions are being made **About the role** We have some great opportunities for Investigators within our Professional Regulation directorate. You will be a highly motivated and enthusiastic individual...

  • Quality Control Investigations Team Lead

    2 months ago

    Edinburgh, United Kingdom JPMorgan Chase & Co Full time

    **JOB DESCRIPTION** As part of the FinCrime Operations function, the Financial Crime Operations Investigations (FCOI) QC team is primarily responsible for performing end to end quality reviews of Financial Crime Investigations, to ensure compliance with firmwide and local regulatory standards for Suspicious Activity Reporting (SAR). Reporting to the QC...

  • Financial Crime Investigations

    1 month ago

    Edinburgh, United Kingdom JPMorgan Chase & Co Full time

    **JOB DESCRIPTION** Are you an experienced Team Leader with a background in the Financial Crime area and looking for your next career opportunity ? As part of the FinCrime Operations function, the Financial Crime Operations Investigations (FCOI) QC team is primarily responsible for performing end to end quality reviews of Financial Crime Investigations, to...

  • Investigator

    7 days ago

    Edinburgh, Edinburgh, United Kingdom The Nursing and Midwifery Council Full time

    Description:About the TeamThe investigation team play an integral role in the Fitness to Practise process to ensure high quality and propionate decisions are being madeAbout the roleWe have some great opportunities for Investigators within our Professional Regulation directorate.You will be a highly motivated and enthusiastic individual who can demonstrate a...

  • 3is Investigator

    15 hours ago

    Edinburgh, United Kingdom Lloyds Banking Group Full time

    End Date Sunday 12 May 2024 Salary Range £31,151 - £32,790 - We support flexible working - click here for more information on flexible working options Flexible Working Options Hybrid Working, Job Share Job Description Summary Economic Crime Prevention provides a high quality, large scale, shared service for customer owning business units in Lloyds...

  • Cra Ii

    2 weeks ago

    Edinburgh, United Kingdom ICON plc Full time

    **Role: Clinical Research Associate** **Location: North of the UK (covering mainly Scotland based sites)** **Fully sponsor dedicated** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device...

  • Cra Ii

    7 days ago

    Edinburgh, Edinburgh, United Kingdom ICON plc Full time

    Role: Clinical Research AssociateLocation: North of the UK (covering mainly Scotland based sites)Fully sponsor dedicatedICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government...

  • Senior Investigations Officer

    3 weeks ago

    Edinburgh, United Kingdom Environmental Standards Scotland Full time

    **Details**: **Reference number**: - 275684**Salary**: - £41,642- This is a permanent and pensionable appointment and new entrants will normally start on the minimum of the pay range.**Job grade**: - Other- B3**Contract type**: - Permanent**Type of role**: - Other**Working pattern**: - Full-time**Number of jobs available**: -...

  • Cra Ii

    3 weeks ago

    Edinburgh, United Kingdom Precision Medicine Group Full time

    Precision for Medicine, Oncology and Rare Disease is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will focus on an average of one to two...

  • Financial Crime Investigator

    2 weeks ago

    Edinburgh, United Kingdom Lloyds Banking Group Full time

    End Date Thursday 27 June 2024 Salary Range £31,151 - £32,790 - We support flexible working - click here for more information on flexible working options Flexible Working Options Hybrid Working, Job Share Job Description Summary **Job Description**: JOB TITLE: Financial Crime Investigator SALARY: £31,151 LOCATION(S): Birmingham*, Edinburgh,...

  • Financial Crime Investigator

    4 weeks ago

    Edinburgh, United Kingdom Mettle Full time

    Our people work differently depending on their jobs and needs. From hybrid working to flexible hours, we have plenty of options that help our people to thrive. This role is based in the United Kingdom and as such all normal working days must be carried out in the United Kingdom. Join us as a Financial Crime Investigator - If you have an analytical mind-set...

  • Investigator Major Cases

    2 weeks ago

    Edinburgh, United Kingdom HSBC Full time

    -Job description Some careers open more doors than others. If you’re looking for a career that will unlock new opportunities, join HSBC and experience the possibilities. Whether you want a career that could take you to the top, or simply take you in an exciting new direction, HSBC offers opportunities, support and rewards that will take you further. FCI...

  • 3is Specialist Investigator

    1 day ago

    Edinburgh, United Kingdom Lloyds Banking Group Full time

    End Date Sunday 12 May 2024 Salary Range £42,120 - £46,800 - We support flexible working - click here for more information on flexible working options Flexible Working Options Hybrid Working, Job Share Job Description Summary Economic Crime Prevention (ECP) provides a high quality, large scale, shared service for customer owning business units in...

  • Deskside Support Engineer Ii

    3 weeks ago

    Edinburgh, United Kingdom Manpower Full time

    **An exciting opportunity has arisen to join a world leading global organisation. Our client, a blue-chip IT company, is currently seeking a Deskside Support Engineer II based on their customer site in Edinburgh. This is a full-time, permanent roleto start ASAP. The role is paying up to £26,680 per annum depending on experience. Working between 08:00 -...