Quality Operations Specialists must assist site management to oversee the quality system execution on the manufacturing and production areas at all times. The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of released batches. Responsibilities: Ensure that products manufactured meet approved company policies, processes and procedures
Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
Release incoming material, process, and product batches.
Participate in investigations arising out of non-compliance in incoming materials, QC te...