Job Description

Manufacturing 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 peoples 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 !
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 Manufacturing Batch Record Reviewer.
• Review executed manufacturing batch documentation (batch records, in-process data and environmental monitoring data) to ensure GMP compliance and adherence to operational SOPs.
• Using a right first time approach, assure all comments and annotations are clear and concise.
• Provide regular feedback on findings during document audit to relevant departments as appropriate.
• Assure timely communication of quality events identified during document audit with relevant departments, including raising deviations.
• Input batch-related data into Manufacturing and QA batch review trackers where applicable.
• Work to ensure timely closure of packs for batch disposition and shipment to patient by working collaboratively with relevant departments.
• Support with daily OQIT housekeeping activities, including but not limited to filing, photocopying and transferring documents to other RoslinCT sites.
• Attend OQIT meetings to provide appropriate feedback in respect status and progression of manufacturing documentation.
• Assist in training and coaching relevant personnel to develop their GMP recording, review and technical writing skills.
• Accountable for maintaining a clean, orderly and safe work environment and adhere to set safety standards.
• Attendance at OQIT meetings to provide appropriate feedback in respect status and progression of manufacturing documentation.
• Assist in training and coaching relevant personnel to develop their GMP recording, review and technical writing skills.

About you

• Experience/educational background in stem cells, gene/cellular therapies or cell banking.
• Experience with following standard operating procedures.
• Awareness/Understanding of cGMP regulations particularly in respect of aseptic processing, documentation, and record management.
• 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.
• For the Manufacturing Batch Reviewer I level position, in addition to all the above, we would expect a minimum 1 years experience in Sterile Manufacture- and/or Quality-related role.

Next Steps
If this sounds like you, then please hit xe2x80x98Apply now! We will ask you to upload your CV and complete a short application form.
At RoslinCT, were all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows theyre valued and encouraged to be themselves, whether theyre our employees, customers, or partners.
We take pride in being an equal opportunity employer. We treat all applicants fairly and dont discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.
If youve got any specific needs or concerns regarding accessibility during the recruitment process, dont hesitate to reach out to us at . Were here to assist and make things as smooth as possible for you.
RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies. It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep. RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.