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Quality Assurance Specialist
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- Ensure that production personnel follows compliance of all Center activities with cGMP, Kedplasma DCOP’s (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.
- Provide accurate reports of the facility’s compliance to QAM, Regional Manager and/or VP of QA/RA.
- Ensure correct documentation and computer use and archiving or backup including donor files.
- Direct observations of performance of routine and quality control procedures including, as applicable, donor suitability, sample handling, processing, testing, labeling, and instrument preventive maintenance;
- Ensure that CLIA proficiency testing, complaint investigations and staff training and certifications are properly performed and documented.
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