Bit Bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy. At Bit Bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.
As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.
Your role in our team:
We are looking for an experienced member of the Quality team to co-ordinate
and manage all document control activities within Bit Bio ensuring compliance with the principles of Data Integrity and all internal and relevant regulatory standards.
The initial aim of this role is to develop and implement processes for the control and management of the Quality Management System (QMS) documentation and assume responsibility for the issuance, tracking and control of Standard Operating Procedures, Master Batch Records, Test Records, forms, Protocols and Final Reports.
There is a requirement to be diplomatic, collaborative, customer focused, change agile, comfortable in leading and adapting to changing priorities in a rapidly growing business.
Your key responsibilities will include:
• Develop system and establish procedures for identification and numbering of document types.
• Create standard templates for QMS controlled documentation.
• Create, revise and maintain company standard operating procedures (SOP’s) and other documents as required.
• Format, revise, track and issue of controlled documents including SOP’s, protocols and other QMS documents as required.
• Manage and assist in the review of cGMP controlled documents as necessary.
• Issuance of batch production records, tracking of master batch records, tracking of all production records and lot number issuance.
• Maintain validation files (validation protocols, validation summary reports, engineering change controls).
• Interface with other departments regarding documentation requirements.
• Co-ordination and maintenance of quality system databases and logs.
• Initiate, complete and maintain change control documents.
• Provide administration support to the Head of Quality and QA Manager.
• Have a degree level or equivalent qualifications in a relevant discipline.
• Are humble - sincere and secure - accepts own mistakes - prioritises team over personal goals.
• Are hungry - driven and proactive - goes above and beyond the call of duty to achieve company results.
• Are smart - astute and persuasive - uses emotional intelligence to assist and collaborate with colleagues.
With essential experience in…
• Documentation Control within a cGMP environment
• Good Manufacturing Practice within a Pharmaceutical or related environment
• Good documentation Practice and principles of Data Integrity.
• Proficient use of Excel, Word and PowerPoint.
• Excellent time management, organisation, and communication skills
• Experienced in working in a scientific / cell therapy environment
• Experienced in Continual Improvement Tools e.g. LEAN, 5S, Kanban, Kaizen, RCA, VSM
• QESH Management System / ISO9001 / PDCA Training
More reasons to join us:
Bit Bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact.
We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other.
Creativity and open minds are encouraged for everyone to contribute to the success of the company.
To support Bit Bio staff and our culture further, we also offer a competitive salary, highly competitive benefits package including pension contribution scheme as well as health and life insurance.
Location: Babraham Research Campus, Cambridge
Type: Full time, permanent / Start: Immediate
Salary: Competitive / Hours: 40 p/w
Office Based Position
Cambridge Start Up of the Year 2018
To be part of our dynamic, growing start-up team and share our vision to build together the leading cell coding company, please send your CV and cover letter to email@example.com