Batch Record Reviewer

Batch Record Reviewer
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 to join our team as a Batch Record Reviewer.
• A key role which will be responsible for performing manufacturing GMP documentation reviews by the mandated closure date.
• Review executed manufacturing batch documentation (Batch Records, in-process data, and environmental monitoring data).
• Ensure GMP compliance and adherence to SOPs through the review and approval of executed manufacturing documentation.
• Using a 'right first time' approach, assure all comments and annotations are clear and concise.
• Communicate any quality events and provide regular feedback on findings during audit.
• Partner with colleagues in investigations, deviations, discrepancies, and technical problem solving as required.
• Work closely and collaboratively with the Operation Quality Improvement team to identify appropriate continuous improvement opportunities.
• Work diligently to ensure timely closure of packs for batch disposition and shipment to patient
  
• Evaluate trends and work pro-actively and collaboratively on targeted initiatives to reduce data errors and deviations.
  
• Assist in training and coaching relevant personnel to develop their GMP recording, review and technical writing skills.
• Provide timely communication and work with Lead Biotechnologists, Section Managers and the Training Academy to conduct sharing sessions with personnel on batch data audit outcomes, investigation outcomes, impacts and CAPAs.

About you

• Experience of cell culture methods and techniques.
• Excellent working knowledge of GMP regulations, particularly in respect of aseptic processing, documentation and record management.
• A strong working knowledge of UK, EU, and FDA regulations.
• You will have experience with technical writing and addressing GMP audit findings.
• Exceptional organisational and planning skills with the ability to multi-task in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to build strong working relationships internally and externally.
• You will be able to create a positive environment through self-awareness and social skills.
• Able to effectively manage and influence stakeholders’ and customer expectations.
• You will be organised, with excellent administration and record-keeping skills.
• Ability to learn and share knowledge with the management team and the wider team where appropriate.
• Excellent attention to detail with a real desire to continually develop and improve our processes.

Qualifications

• A BSc in a Life Science subject or other equivalent laboratory experience.

Next Steps

If this sounds like you, then please hit ‘Apply’ now! We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you!

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.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.