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This position supports the Quality team in the release of raw materials and finished products, general administration for the QMS, and aids the release of Laboratory Operations service results.
Role Description
Overall responsibilities:
1. Perform QC of raw materials used in manufacturing, including inspection and release of items requiring CofA/packaging checks.
2. Conduct laboratory testing and release of kit components using the T-SPOT assay platform.
3. Assist with QA review and control of QMS documentation, including proper handling and storage, both physically and electronically using OI’s ERP system.
4. Support NCR and CAPA investigations as needed.
5. Perform activities to support manufacturing in product release, such as:
* 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.
* Review of documentation related to heat treatment and sterilization of critical consumables.
* Review of bioburden certificates, including investigating out-of-specification results.
* Create product CofAs.
* Clean laboratory equipment and maintain cleaning records.
* Prepare media aliquots.
* Verify non-critical laboratory equipment, e.g., internal pipette verification.
* QC of patient test results from Laboratory Operations under ISO 17025:2017/GCP standards.
* Assist in monitoring compliance with QMS and tracking systems related to ISO 13485:2016, ISO 17025:2017, and QSR.
* Help the Director of Quality ensure the effectiveness of the QMS.
* Perform miscellaneous duties such as updating QMS documentation via eQMS, maintaining and disposing of quality stock, and ensuring audit readiness.
* Control and manage stock both physically and electronically using OI’s ERP system.
Specific deliverables:
* Monitor product conformity through incoming QC.
* Assist in ensuring no major non-conformances during external audits for GCP, GMP, MDSAP, ISO 13485:2016, and ISO 17025:2017.
* Contribute to maintaining product quality aligned with company goals.
* Uphold Revvity’s company values at all times.
Role Requirements
Technical skills and abilities:
* Degree in a relevant scientific field or relevant technical/practical experience.
* Proficiency in computer use, MS Office, and internet.
Emotional skills and abilities:
* Pleasant disposition with a cooperative attitude.
* Attention to detail and a quality-focused mindset.
* Strong numeracy and literacy skills.
* Ability to work under pressure.
* Ability to work independently and as part of a team.
* Careful work approach, aiming for first-time correctness and identifying non-compliance.
Competence Level
* Compliance & Integrity
* Customer Focus
* Personal Learning
* Accountability
* Building Effective Teams
* Working towards a common goal
* Communication & Relationships
* Perseverance
* Creativity & Innovation
What we offer
* A purposeful and inclusive work environment.
* A dynamic culture prioritizing customer needs.
* Being part of a highly qualified team committed to excellence.
* Access to cutting-edge expertise to make a positive impact in the world around us.
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