Quality Assurance and Regulatory Affairs Specialist
Origin Sciences
Quality Assurance and Regulatory Affairs Specialist
Salary Not Specified
Origin Sciences, Newtown, Cambridge
- Full time
- Permanent
- Onsite working
Posted 2 weeks ago, 4 May | Get your application in now before you miss out!
Closing date: Closing date not specified
job Ref: f24ed9fe6cd041fb82b1d16173cba095
Full Job Description
- Contribute to the development, maintenance, and compliance of the Quality Management System (QMS). With understanding of ISO: 13485. This Role is more QA but knowledge of RA beneficial.
- Support the implementation and maintenance of the Origin Science electronic QMS (Greenlight Guru).
- Prepare, review, and implement ISO:13485 compliant SOPs for functions across the business.
- Contribute to the investigation and analysis of non-conforming product and processes, and CAPA activities.
- Contribute to the companies Quality Management Review process.
- Act as an internal auditor of Origin Sciences products, process and systems.
- Contribute to BSI ISO:13485 audit activities.
- Assess critical suppliers ongoing suitability, developing and maintaining the appropriate supplier quality agreements.
- Contribute to the development and maintenance of the Origin Sciences customer complaints procedures.
- Perform or verify performance of direct reports on completion of QMS duties including but not limited to: specification and process development and implementation, material, part and device inspection and non-conforming materials handling in collaboration with operations, feedback / complaint handling in collaboration with customer service, and CAPAs in collaboration with all departments.
- Contribute to QMS Management Review meetings which includes preparation and distribution of reports regarding the quality system, quantification the organization's performance relative to quality objectives and overall QMS effectiveness.
- Function as liaison with external parties on matters relating to the quality management system such as quality audits by outside parties.
- Support RA Manager with clinical study documentation, risk management and reports.
Origin Sciences is a start-up biotechnology company based in Granta Park, just south of Cambridge. We develop our own innovative medical devices, which we use in clinical trials to collect a biobank of mucus-based biospecimens. This biobank provides clinical material for our research and development streams to assist with diagnostic development. - 25 days holiday
- Pension contribution
- Hybrid Working
Our primary disease area is Colorectal Cancer (CRC). We are creating a minimally invasive and accurate CRC diagnostic, which will allow the NHS to focus resources on patients with more serious pathologies. Our motivations are to reduce NHS waiting times, enable earlier CRC detection and reduce unnecessary investigations performed on healthy patients.
Our CRC diagnostic is analogous to blood-based liquid biopsies. However, we have the advantage of evaluating material that was collected closer to the pathology of interest.