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QA / RA Specialist II
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- Quality Assurance/Regulatory Affairs Specialist II: Molecular Diagnostic Products
- Bachelor of Science degree in Life Sciences and 5+ years of employment in a cGMP regulated facility and 2+ years of experience in Quality Assurance.
- Knowledge of In Vitro Diagnostic Regulation (IVDR) is required.
- Reviews and approves all MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs)and Corrective and Preventive Actions (CAPAs).
- Participates in, and may conduct, internal, customer, FDA, and ISO audits.
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