QA Specialist Aseptic Operations (3rd shift)
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About The Position
The Quality Assurance Specialist supports quality systems as they relate to the manufacturing and testing of cGMP drug products. This role involves providing oversight and general support for the manufacturing of aseptic processes, deviation and CAPA systems, batch record review, SOP creation and revision, and review of quality documents. The Quality Assurance Specialist plays a crucial role in supporting the Quality Management System, ensuring compliance with established procedures and documentation during operations. In this position, the specialist will be responsible for providing on-the-floor quality oversight within the warehouse and manufacturing areas, ensuring compliance with procedures and manufacturing documentation. This includes establishing and maintaining good technique in classified areas, including gowning qualification. The specialist will also review and approve executed batch records and other associated controlled documents, perform QA reviews of in-process and environmental monitoring test results, and oversee material release for incoming materials. Additionally, participation in cross-functional teams to support quality investigations is expected, along with performing tasks within the quality systems while understanding the correlation between systems, such as the relationship between a deviation and CAPA. The role is designed for individuals who exhibit values of quality, service, collaboration, and courage, and who are interested in making a difference in their community and the world. Grand River Aseptic Manufacturing (GRAM) fosters a diverse, community-minded culture where employees can grow and learn while improving lives every day.
