Quality Assurance Professional
1 week ago
At Cepheid, we are passionate about improving healthcare through fast, accurate diagnostic testing. As a Quality Assurance Specialist, you will play a vital role in supporting our Operations activities and ensuring the maintenance of Quality System documentation.
Key Responsibilities- Review records and documents for completeness and compliance with regulatory requirements and ISO standards.
- Review Batch Records/all Device History Records (DHR)/Electronic Batch Records (eDHR) to support the release of raw materials, work in progress, and final products.
- Collaborate with other function teams to resolve batch record discrepancies or errors as it relates to Good Documentation Practice.
- Review and assist in improving standard operating procedures/operation process and quality system functions.
- Support the Material Review Board for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Report, as needed.
- Support PDR closure, as needed.
- Participate in supplier/vendor qualification and evaluation.
- Prepare and implement quality assurance policies and procedures as per requirements.
- Perform routine process audits.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.
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Quality Assurance Professional
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Software Quality Assurance Professional
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