Batch Record Reviewer

We are looking for a driven individual to join us as a Batch Record Reviewer.

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 within the Pharmaceutical or Biologics industries.

The Role:
You will be a key member of our Operational Quality Improvement team and will be responsible for performing Manufacturing GMP documentation reviews, ensuring GMP compliance, in support of the manufacture and delivery of our life-changing cell and gene therapy products. The ideal candidate will hold experience in working to cGMP regulations.

Responsibilities:
As a key member of a cutting-edge company your responsibilities will be varied but will include;
* Reviewing Manufacturing batch documentation to ensure GMP compliance and adherence to operational SOPs, including batch records, deviations, in-process data and environmental monitoring data.
* Providing timely communication of quality events and audit findings to the wider company.
* Participating in investigations, deviations, discrepancies and technical problem solving as part of the Operational Quality Improvement team.
* Ensuring timely closure of packs for batch disposition and shipment to patients.
* Assuring all procedures have been followed and non-conformances identified.
* Input into other Quality Management work such as Change Controls, Risk Assessments, FMEA, document updates and CAPA implementation.
* Working closely and collaboratively with the Operation Quality Improvement Team to identify appropriate continuous improvement opportunities.
* Ensure various Manufacturing and Quality Assurance trackers are kept up to date.
* Evaluation of trends and development of targeted initiatives to reduce data errors and deviations.
* Training and coaching of relevant personnel to develop their GMP recording, review and technical writing skills.
* Working with Lead Biotechnologists, Section Managers and the Training Academy to conduct sharing sessions with Biotechnologists on batch data audit outcomes, investigation outcomes, impacts and CAPAs.

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

Skills and Experience:
You will be able to demonstrate:
* 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.