Quality Investigator

We are looking for a driven individual to join us as a Quality Investigator.

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 at the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

As part of our continued growth, we are now recruiting across all of our teams including this Quality Investigator role. This role is well suited to an individual with experience in GMP Manufacturing, looking to specialise in Quality.

The Role:
You will be a key member of our Operational Quality Improvement team and hold responsibility for performing detailed and thorough investigations of non-compliances in our cell and gene therapy Manufacturing processes including impact assessments, root cause analyses and identification of CAPAs. The ideal candidate will hold experience in working with a GMP Quality Management System and cGMP regulations.

Responsibilities:
As a key member of a cutting-edge company your responsibilities will be varied but will include;
* Conducting and summarising technical deviations and incident investigations, translating complex operational events into an understandable and cohesive summary reports.
* Analysis of events and assessment of impacts in the context of the sterile medicines cGMP regulations.
* Leading and performing systematic root cause analyses to determine most likely causes.
* Working closely with all departments to identify appropriate, effective CAPAs and facilitate deviation closure.
* Identification of realistic and effectual CAPAs.
* Performing ‘in the field’ investigations, collecting data and interviewing involved personnel.
* Ensuring timely completion and closure of deviations and investigations.
* Review and update of SOPs, policies, and processes to ensure all quality standards are in compliance with GMP standards.
* Present status updates of root cause analyses and findings to RoslinCT management, clients, client auditors and regulatory inspectors.
* Training and coaching of relevant Operational personnel to develop their technical writing and investigation skills.
* Working with Lead Biotechnologists, Section Managers and the Training Academy to conduct sharing sessions with Biotechnologists on investigation outcomes, impacts and CAPAs.
* Evaluating trends and development of targeted initiatives to reduce deviations.
* Input into other Quality Management work such as Change Controls, Risk Assessments, FMEA, document updates and CAPA implementation.
* Assist with Manufacturing document batch review process as required.

Qualifications:
​You will hold a Life Science degree or equivalent relevant experience.

Skills and Experience:
You will be able to demonstrate:
* Experience working with a GMP Quality Management System.
* Excellent working knowledge of cGMP regulations particularly in respect of aseptic processing, documentation and record management.
* Working knowledge of UK, EU and FDA regulations.
* Experience with technical writing and addressing GMP audit findings.
* Experience of cell culture methods and techniques would be desirable, although not essential.

Benefits:
In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we offer:
* ​31 days of annual leave, plus 4 public holidays - when you have been with us for three years, we will give you an extra day holiday every year and when you reach 5 years, you’ll get an extra two days holiday every year.
* Competitive company pension scheme – we contribute up to 8% of your salary (depending on length of service) to ensure that you are all set for the future.
* Group Life Cover – you are automatically covered for three times your basic salary to give you peace of mind for you and your family.
* Healthcare Cashback, Mental Health/Wellbeing support and gym discounts via our Healthcare plan.
* Staff discounts on food, drink, electronics, entertainment and electricals.
* Access to our Cycle2Work Scheme so you can save up to 42% on a new bike to help with your commute and wellbeing.
* We have a dedicated Social Committee and other regular company events such as BBQs, team drinks, quizzes, parties and 5-aside football.
* Career Progression & Training Opportunities are provided for all of our staff to help you achieve your goals and grow professionally and personally.

Values:
A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
* Passion for customer satisfaction.
* Ability to support a ‘one team’ approach.
* Great communication.
* Commitment to personal growth and development.
* Accountability for your work.

Location:
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.

Employer Value Proposition:
RoslinCT is seeking the best, brightest, and most passionate cell and gene therapy talent with a diverse range of skillsets, experience, and perspectives. We offer industry-leading annual leave allowances, career development opportunities and employee benefits, as well as working groups and social activities, and are dedicated to developing the next generation of experts and future leaders of our company. If you want to utilise your skills and talent in a state-of-the art company that truly changes lives, you belong at RoslinCT.