QA Officer

**Salary**:c. £24,000 - £26,000

**Location**:Gateshead

**Contract**:Permanent

**Start Date**:Immediate

Are you looking for Quality Assurance opportunities within the Biotechnology and Life Science Industries? A fantastic opportunity to join a growing Biotech company based in Gateshead has recently come available.

As a **QA Officer**, you will be responsible for maintaining the Quality management system, ensuring that the manufactured products are produced and distributed in accordance with the correct Standards and regulations.

**Your responsibilities will include**:

- Maintenance of the Quality Management System in compliance with appropriate International Standards & Regulations for the manufacture of IVD products. As well as evaluation and improvement of QMS.
- Review batch manufacturing records to ensure adherence to requirements leading to the QA Release of products. Additionally, assist in non-conformance investigations, root cause analysis and implementing CAPA for process concerns.
- Work with R&D and Operations departments to ensure the efficient and compliant transfer of new products from R&D to production.
- Assessment and approval of changes to ensure quality impact analysis, risk management and validation activities are identified and carried out.
- Conduct internal quality audits and assist with external audits.
- Investigation and analysis of failure, corrective and preventive action to respond to customer complaints. Including assessment of potential reportable events, suppliers/distributors assessments, approval and re-evaluation.
- Creation, maintenance and approval of all QMS documentation, including archiving and reviews, assist in training and promoting QA awareness throughout the company.
- Completion and analysis of QA Metrics towards Quality Management Reviews.
- Deputise for QA Lead and assist in the delivering of training to build quality awareness.
- Review, approval and administration of Product Notifications as well as preparation of preparation of post market surveillance reports.
- Monitor the progress of quality activities on a daily/weekly basis ensuring that there is continuous drive/focus on meeting target dates and KPIs. As well as administration of on-line training system.

**About you**:

- You will hold a relevant Scientific degree.
- Excellent data analysis skills, as well as great attention to detail.
- Knowledge and competency in using Microsoft and other software.
- Demonstratable knowledge of medical devices or scientific industries. As well as ISO 13485.
- Effective attention to detail and the ability to work well in a team or independently.