- To assist with the QC of raw materials used for manufacturing and QC.
o Incoming QC of items requiring CofA/packaging checks
- Perform document control activities using electronic QMS (EtQ)
- Assist the Equipment team in scheduling equipment due for calibration and carry out QA review of equipment certificates
- Aiding the validation of procedures, processes and equipment
o Carry out testing where required following a planned procedure
- QA review of completed logs, forms and monitoring data
o Temperature logger data, receipt of goods, other forms
o Aiding with the completion of risk assessments, e.g. for out of specification equipment
- Assisting with the control of Quality Management system documentation
o Issuing of manufacturing documents and labels
o Scanning of Quality documents
o Auditing QC records
- To assist with the QC of results from the ODL testing service
- Assisting with the monitoring of compliance with the QMS and with tracking systems associated with ISO 13485:2016 and ISO 17025:2005 and the QSR
o Reviewing staff training records
- Assist the Senior Quality Manager to ensure the continuing effectiveness of the QMS
- Assist during internal and external audits as required
- Perform miscellaneous duties as necessary
Specific deliverables for the role are:
- Contributing towards the maintenance of the quality of OI products in fulfillment of OI’s Company goals.
- Monitoring of product conformity through incoming QC, archive kit and stability testing
- Assisting with ensuring compliance in the manufacturing process and documentation
- Ensure that areas of responsibility do not contribute to any major non-conformance during external audits for GMP, ISO 13485:2016and ISO 9001:2008.
- Working to Oxford Immunotec’s Company Values at all times.