GxP TECHNICAL ADMINISTRATOR
MILTON PARK, ABINGDON | FULL TIME
As a GxP Technical Administrator at 30 Technology, your responsibilities will be to manage cross-departmental administrative activities that facilitate the smooth running of Regulatory/Quality Assurance (QA) and Technical Operations laboratory associated processes; you will oversee and maintain databases, collate data, draft regulatory documents, work closely with the quality team and work with vendors and contractors. You’ll ensure that laboratory equipment is procured by supporting the Head of Technical Operations, tracked, maintained including its GxP validation status, and that documentation is complete, accurate and filed. You will oversee the administrative management of the Quality Management System (QMS) under the guidance of the Head of Quality Assurance to ensure the health of the QMS. This will include ensuring all controlled documents are available, up to date and tracked, issued, trained on and retired, management and quality control (QC) of training records and required training. You will also be involved in assisting all teams including senior management, as needed for any structural and/or ancillary tasks as well as carrying out basic laboratory techniques and methodologies after appropriate training.
Working at the very heart of the 30 Technology teams, your role will involve daily liaising with all functional team members and having to juggle multiple tasks at a time. You will be highly organised and have the attitude that ‘no task is too small’ when carrying out office, QA and lab administrative/regulatory duties. This office based role will be at our Milton Park site, Abingdon. Working from Home can be considered once the role has been established and is functioning successfully.
- Liaise with vendors to procure quotes and purchasing laboratory equipment, consumables and supplies
- Keeping records of lab expenditure, equipment validation status, assisting with validation activities
- Set up and maintain scientific databases, including data management, tracking of documentation and data and its associated filing
- Oversee metrology logs to ensure annual PM/PQ of equipment is carried out in a timely manner
- Draft and review quality documents to support laboratory equipment and method validations
- Be able to process and interpret large data sets
- Manage administrative activities for the Quality Management System including maintaining the effective controlled documents list, management of deviation and CAPA logs, follow up with staff to ensure in time document updates, management of training files and assist in the management of training including QC of records on a quarterly basis
- Being able to “muck in”/help out with whatever is needed to keep the laboratory and office running smoothly!
- A minimum of BSc degree Biological Sciences, Chemistry or equivalent
- Having worked in a regulatory environment will be a great advantage – GCP, GLP, GMP experience
- Excellent organisational and time-management skills
- Strong IT skills and knowledge of Microsoft Office Suite (Word, PowerPoint, Excel)
- A knowledge of Computer System Validation is advantageous
- The ability to prioritise tasks, work under pressure and with minimum supervision
- Excellent interpersonal, oral and written communication skills
- Strong attention to detail
- A problem-solving approach to work
Desired – But Not Essential Experience
- Be familiar with basic scientific systems and processes
30 TECHNOLOGY is developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.
30 TECHNOLOGY Therapeutic Nitric Oxide