Quality Control Technician

Job Overview: Quality Control Technician

Company: Oxford Immunotec
Location: Abingdon, UK
Position Type: Fixed-Term, 9 months
Work Arrangement: On-site

Company Overview: Oxford Immunotec, a Revvity company is a leading global diagnostics company dedicated to bringing energy and innovation to the field of diagnostic testing. We offer regulated ELISPOT assays for T cell measurement, providing diagnostic solutions approved around the world.

Role Summary: Oxford Immunotec is seeking a Quality Control Technician to join our team for a fixed term of 9 months. This role supports the Quality team in the release of raw materials and finished products, assists with general administration for the Quality Management System (QMS), and aids in the release of Laboratory Operations service results. As part of the quality team, you will ensure compliance with regulatory standards and support quality processes that maintain the highest standards of product quality and service.

Role & Responsibilities:

1. Performing the QC of raw materials used in the Manufacturing process, including:

- Inspection and release of items requiring CofA/packaging checks.

- Laboratory testing and release of kit components using the T-SPOT® assay platform

2. QC of patient test results from the Laboratory Operations testing service under ISO 17025:2017/GCP requirements

3. Assisting with QA review and control of QMS documentation, including:

- Appropriate handling and storage of documentation, physically and electronically using OI’s ERP system.

- Assisting with NCR and CAPA investigations, as required.

- Equipment certificate handling.

4. Performing critical activities to support Manufacturing in product release, including:

- In-process Quality checks of Manufacturing operations.

- Review and approval of kit and kit component labels.

- Review and approval of Manufacturing batch records for labelling and assembly operations.

- Review of documentation for the heat treatment and sterilisation of consumables critical for the manufacturing process.

- Review of bioburden certificates, including investigation of out of specification results.

- Creation of product CofAs.

5.Performing general laboratory maintenance, such as:

- Cleaning of laboratory equipment and maintenance of cleaning records.

- Preparation of media aliquots.

- Verification of non-critical laboratory equipment e.g., internal pipette verification.

6. Assisting with the monitoring of compliance with the QMS and with tracking systems associated with ISO 13485:2016 and ISO 17025:2017 and the QSR.

- Assist the Director, Quality to ensure the continuing effectiveness of the QMS.

7. Perform miscellaneous duties as necessary, such as:

- Updates of QMS documentation following the Document Control process using the eQMS.

- Maintaining and disposing of Quality stock.

- Ensuring the department is audit ready at all times.Control and movement of stock, both physically and electronically using OI’s ERP system.

Specific deliverables for the role are:

- Monitoring of product conformity through incoming QC.

- Collaborate and assist to ensure that areas of responsibility do not contribute to any major non-conformance during external audits for GCP, GMP, MDSAP, ISO 13485:2016 and ISO 17025:2017.

- Contributing towards the maintenance of the quality of products in fulfillment of Company goals.

- Working to Revvity’s Company Values at all times.

Role requirements

Technical skills and abilities:

- Educated to degree in a relevant scientific subject or with relevant technical/practical experience

- General use of computers with MS programs and the Internet

Emotional skills and abilities

- Pleasant disposition with a co-operative attitude

- Attention to detail and Quality ‘mindset’

- High standard of numeracy and literacy

- Conscientious

- Able to work under pressure

- Work well alone and as part of a team

- Works carefully to get things right the first time and identifies non-compliance.

Competence Level

Foundation Level

- Compliance & Integrity

- Customer Focus

- Personal Learning

- Accountability

- Building Effective Teams

- Working to a common goal

- Communication & Relationships

- Perseverance

- Creativity & Innovation

What we offer

- Purposeful & inclusive work environment

- Dynamic culture in which customers are at the forefront 

- Being part of a highly qualified team that is committed to excellence  

- Access to cutting-edge expertise through which you can make positive impact in the world around us­­