The QA Specialist is responsible for day-to-day administration of Quality Assurance programs in support of the company's Quality Management System. The QA Specialist will be involved in the development, implementation, and maintenance of Quality System processes to meet the requirements of US FDA (e.g., 21CFR 820, ISO 13485), and other applicable quality and regulatory standards.
Works with relevant departments to ensure successful implementation of quality systems and communicates the impact of changes to areas affected to ensure that the changes are integrated into day to day operations.
??? The primary responsibility for this position to perform the review and release of Design History Files (DHF). Work with R&D and Regulatory Affairs to ensure that DHF are complete and compliant.
??? Perform routine QA responsibilities which include reviewing Device History Records (DHR) for finished goods release.
??? Identifies quality improvement in areas of responsibility.
??? Support Quality System audit activities including internal audits, supplier audits, and regulatory body audits.
??? Prepare quality reports, data, and key performance indicators for management reviews.
??? Assist with other duties which include CAPA and NCR investigations. This includes ensuring proper handling, quarantine and disposition of discrepant material.
??? Identify top issues and recommend CAPAs/SCARs and drive to closure where required.
??? Other such duties as determined by QA Supervisor or Quality Manager.
Working hours: 8:00 AM - 4:30 PM
--BS or MS in Chemistry/Biochemistry, Biology or related field
--2 to 5 years of experience working in a regulated environment in Quality in the biotech industries.
--Working knowledge with domestic and international Quality System Regulation requirements for the In Vitro Diagnostic industry; e.g., 21CFR Part 820, ISO 13485:2016, and/or IVD Directive.
--Must have excellent interpersonal skills, writing skills, and communication skills.
--Good organizational skills and attention to detail.
--Ability to work independently
--Experience working in ISO 13485 and/or FDA regulated industry
--Good computer skills, PC including MS Excel a must.
--Knowledge of SAP and/or SAP NEXT preferred.
Temp to hire position
Benefits available after 45 days
Interested? Please email Rebecca.Ricksgers@external.emdmillipore.com or call my desk line at 951-514-4501!
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