Quality Assurance Specialist
1 week ago
This role supports the Quality team in the release of raw materials and finished product, general administration for the QMS, and aids the release of Laboratory Operations service results.
Key Responsibilities:- Performing the QC of raw materials used in the Manufacturing process, including inspection and release of items requiring CofA/packaging checks, and laboratory testing and release of kit components using the T-SPOT assay platform.
- Assisting with QA review and control of QMS documentation, including appropriate handling and storage of documentation, physically and electronically using OI's ERP system, and assisting with NCR and CAPA investigations as required.
- 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, and review and approval of Manufacturing batch records for labelling and assembly operations.
- Performing general laboratory maintenance, such as cleaning of laboratory equipment and maintenance of cleaning records, preparation of media aliquots, and verification of non-critical laboratory equipment.
- QC of patient test results from the Laboratory Operations testing service under ISO 17025:2017/GCP requirements.
- 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.
- 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, and control and movement of stock, both physically and electronically using OI's ERP system.
- Educated to degree in a relevant scientific subject or with relevant technical/practical experience.
- General use of computers with MS programs and the Internet.
- 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.
- Foundation Level.
- Compliance & Integrity.
- Customer Focus.
- Personal Learning.
- Accountability.
- Building Effective Teams.
- Working to a common goal.
- Communication & Relationships.
- Perseverance.
- Creativity & Innovation.
- 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.
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