The Quality Assurance Specialist performs a wide range of responsibilities to support the site’s Quality Assurance program with minimal supervision. This role ensures compliance with internal procedures, regulatory expectations, and industry standards while providing oversight of manufacturing, facilities, utilities, and quality systems. The specialist serves as a key QA representative across cross‑functional teams, leads investigations and audits, and supports the release of products and systems.

FUNCTIONS

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Review and approve Environmental Characterization reports.
• Review and approve Work Orders and EMS/BMS alarms.
• Review and approve risk assessments and planned incidents.
• Approve nonconformance investigations and CAPA records.
• Approve change controls and ensure compliance with q...