Quality Associate-II, QA Assurance

What you'll be doing

• Provide front line day‑to‑day assistance on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality.
• Support during assigned shift, with the requirement to support plant overtime and planned shutdowns when applicable.
• Provide technical assistance on review and approval of department‑related procedural changes, product quality concerns, reinspections, new product introductions, and protocols.
• Support timely follow‑up on quality exceptions and their preventative/corrective actions.
• Support initiation, investigation and approvals of non‑conformance events in the Trackwise system.
• Act as SME for Electronic Batch Record (EBR) and SPC or equivalent experience.
• Perform change control assessments/executions and approvals.
• Ensure control of defective WIP materials (quarantine, retention, and ...