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QMS Associate
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Full-time
- QA Associate QMS
- The QA Associate ensures quality and compliance of the facility with applicable regulatory requirements.
- Conduct routine walk-throughs of manufacturing areas for adherence with SOPs and good documentation practices including but not limited to sample management and accountability, data integrity (manufacturing, calibration and maintenance logbooks, batch record documentation) and adherence with applicable safety requirements.
- Perform regularly scheduled, formalized internal audits of manufacturing areas for adherence with SOPs, cGMPs, FDA, OSHA, EPA and DEA regulations.
- Review and maintain Quality Management Records (Change control, Deviation, CAPA, Root cause Investigations, Market complaints, Product recall, OOS and Outliers) to ensure compliance with procedures and assurance of due date requirements.
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