Position Overview
This position supports the Quality team in the release of raw materials and finished products, general administration for the QMS, and aids in the release of Laboratory Operations service results.
Responsibilities
1. Quality Control of Raw Materials and Finished Products:
2. Quality Assurance Support:
Assist with QA reviews and control of QMS documentation.
Ensure the proper handling and storage of documentation, both physically and electronically via OI’s ERP system.
Support Non-Conformance Reports (NCR) and Corrective and Preventive Action (CAPA) investigations.
Manage equipment certification and documentation.
3. Manufacturing Support for Product Release:
Conduct in-process quality checks of manufacturing operations.
Review and approve kit and component labels, as well as manufacturing batch records.
Oversee documentation related to heat treatment and sterilization of critical consumables.
Investigate out-of-specification bioburden results.
Generate product CofAs.
4. General Laboratory Maintenance:
5. QC of Patient Test Results:
6. Compliance Monitoring and QMS Tracking:
Assist with tracking systems associated with ISO 13485:2016, ISO 17025:2017, and QSR.
Support the Director, Quality in ensuring the continued effectiveness of the QMS.
7. Miscellaneous Duties:
Update QMS documentation following the Document Control process using the eQMS.
Manage and dispose of quality stock as needed.
Ensure the department is always audit-ready.
Control and manage stock movement through OI’s ERP system.
Key Deliverables:
Monitor product conformity through incoming quality control.
Collaborate to ensure that areas of responsibility do not contribute to non-conformance during audits (GCP, GMP, MDSAP, ISO 13485:2016, ISO 17025:2017).
Contribute to maintaining product quality in alignment with company goals.
Uphold Revvity’s Company Values in all interactions and work activities.
Candidate Requirements
Technical Skills and Abilities:
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.
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 a positive impact in the world around us
Apply today to join our team and help us make a difference!
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