A brand-new role has been created for a Document Controller, to join a fast-growing cell therapy organisation in Stevenage, Herts, who are devoted to tackling cancer. We are looking for a hard-working individual with strong administrative skills gained within a Quality function. If you are proficient in the use of software applications such as Word, Excel and Electronic Documentation Management Systems (EDMS) / Quality Management systems (eQMS), this could be a great career opportunity.
This is a permanent position, paying a very generous salary, annual bonus and healthcare, to discuss on application. Your role will be based in Stevenage, though flexibility can be provided for some remote working and can be discussed.
Reporting to the QA Director, you will support QA, as well as Production, Reg Affairs and Supply Chain teams, regarding to QA/GMP administrative and document management tasks. You will help to ensure efficient and timely manufacturing of cell therapy products for Phase 1 and Phase 2 clinical trials.
Your duties will include:
- Liaising with Production, Quality Control, Quality Assurance, Regulatory Affairs and Supply Chain personnel to manage GMP controlled document issuance, distribution, reconciliation, archival and destruction activities.
- Supporting QA team members with administrative tasks such as filing, printing and copying.
- Supporting Quality Assurance team with general QA activities where required.
- Providing document control and role associated training to site personnel.
- Maintaining and supporting processes for quality metrics reporting.
- Maintenance of reliable document storage and archiving systems, both paper-based and electronic, to maintain the integrity of the records.
- Providing regular reports as required for quality meetings, executive meetings.
Skills and Experience Required:
We are looking for an adaptable, energetic, collaborative, honest and versatile person to join this pioneering company who are at the forefront of T-cell therapy.
- Strong experience in QA document control/administration in a GMP manufacturing environment (ideally sterile pharmaceuticals, ATMP or biologics).
- Minimum second level education or national diploma level
- Proficiency in the use of computers and software applications such as Word, Excel and Electronic Documentation Management Systems (EDMS)/Quality Management systems (eQMS).
- Comfortable in a fast-paced small company environment with minimal direction.
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role in Stevenage, Hertfordshire.