Specialist QA

Quality Assurance Specialist to support quality operations in a GMP-regulated pharmaceutical environment. This role is responsible for ensuring compliance across manufacturing, packaging, and site systems, with a strong emphasis on documentation review, system approvals, and cross-functional collaboration.

• Review and approve product Master Production Records (MPs) and batch documentation.
• Approve process validation protocols and reports for manufacturing processes.
• Participate as QA representative in incident triage teams and New Product Introduction (NPI) projects.
• Approve Environmental Characterization reports and planned incidents.
• Release sanitary utility systems and support facilities and environmental programs.
• Lead investigations and site audits; own site quality program procedures.
• Act as designer for QA Manager on local Change Control Review Board (CCRB).
• Review risk assessments and support automation activities.
• Review and approve Work Orders, EMS/BMS alarms, and change controls.
• Approve non-conformance investigations and CAPA records.
• Provide lot disposition and authorize product lots for shipment.

Available for 12 hrs shift (5am to 5:30pm and/or 5pm to 5:30am)