Quality Control Scientist

This position is responsible for carrying out T-SPOT® assays and other processes during validation of procedures, QC of finished product and raw materials, and to support the Quality Manager in the running of the Quality Management System and general administration of documentation for the QMS. This will include the following:

Overall responsibilities:
1. Maintenance of reference material, including cell culture and stock validation
2. QC of raw materials, incoming goods and any product manufactured by Oxford Immunotec
3. QC of manufactured products and assembled kits
4. Validation of procedures, equipment and software
5. Planning and conducting of stability testing procedures
6. Performing other laboratory testing as required
7. Maintaining the equipment databases to ensure all equipment is calibrated, maintained and serviced as required
8. Assisting with the control of Quality Management system documentation
9. Assisting with the preparation of further documentation for the Quality Management system
10. Assisting with the monitoring of compliance with the QMS and with tracking systems associated with CLIA, CAP, State requirements, ISO 13485:2012, ISO 9001:2008 and ISO 17025:2005 and the QSR
11. Assist the Quality Manager to ensure the continuing effectiveness of the QMS
12. Assist during internal and external audits
13. Conduct laboratory spot check audits
14. Assist with the QA review of documentation including non-conformances, CAPAs and complaints
15. Perform miscellaneous duties as necessary and requested by the Quality Manager

Specific deliverables for the role are:
1. Contributing towards the maintenance of the quality of the Company’s products in fulfillment of the Company goals
2. Control and conduct of product stability testing to support expiry dates and shipping claims
3. Monitoring of product conformity through archive kit testing
4. Assisting with ensuring compliance in the manufacturing process and documentation
5. Ensure that areas of responsibility do not contribute to any major non-conformance during external audits for GMP, ISO 13485:2003, ISO 17025:2005 and ISO 9001:2008
6. Regular communication with QA/QC team members and other functional groups to provide QC and validation support for both Process and Design controls
7. Working to Oxford Immunotec’s Company Values at all times.
8. Follows all company safety policies & other safety precautions within work area
9. Regular attendance and timeliness is essential