QA Specialist I
As the primary QA contact for manufacturing Make-Asses-Release activities, you will oversee investigation initiation support, review batch records/logbooks, manage inventory, and supervise drug product/sample activities.
Your responsibilities include reviewing and approving documentation, supporting deviation investigations, collecting relevant information, and ensuring timely communication of monthly metrics.
Maintain efficient document preparation and management, ensuring compliance with site and global procedures. Drive/support quality system improvement projects through change control, CAPA, and risk assessment.
Qualifications: BS Degree, 2+ years of related experience, and familiarity with electronic document management systems preferred. Strong organizational skills required.
*Detailed job description to be provided.